Endoscopic medical device for dispensing materials and method of use

ABSTRACT

A medical device including an application device with a first fluid path and a container movably attached to the application device. The container and the application device have a second fluid path therethrough, the container includes an inner chamber that is intermediate proximal and distal portions of the second fluid path, the inner chamber is fluidly isolated from the proximal portion of the second fluid path at a first position of the container, and the inner chamber is fluidly coupled to the proximal and distal portions of the second fluid path at a second position of the container. The first fluid path bypasses the container and the passage of fluid through the first fluid path is separately controllable from the passage of fluid through the second fluid path.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority from U.S. ProvisionalApplication No. 62/740,242, filed on Oct. 2, 2018, U.S. ProvisionalApplication No. 62/747,863, filed on Oct. 19, 2018, U.S. ProvisionalApplication No. 62/831,900, filed on Apr. 10, 2019, and U.S. ProvisionalApplication No. 62/848,226, filed on May 15, 2019, each of which isincorporated by reference herein in its entirety.

TECHNICAL FIELD

The present disclosure relates generally to medical systems and devicesfor delivering pressured fluids, and more particularly, to methods andtools for controlling hemostatic agents and achieving proper tissuecontact with the agent at an appropriate pressure and flow rate.

BACKGROUND

Delivery systems and devices are used to supply various materials, suchas powders, during medical procedures. These procedures may includesupplying powders using fluids, e.g., propellant fluids, within a rangeof appropriate pressures and/or flow rates. These powders may includehemostatic agents optimally delivered to tissue at an appropriatepressure and/or flow rate, for the particular application.

Conventional endoscope devices for dispensing fluids, powders, and/orreagents in a patient include advancing a catheter to a target sitewithin the patient and subsequently dispensing the fluid. Drawbacks ofconventional devices include, for example, clogging of the catheter withthe fluid or powder, kinking of the catheter, large variations in theflow rate and pressures of fluids during dispensing, and inconsistencyin the material dispensed at the target site. Further, medical fluiddelivery systems often require delivering a fluid from a high pressurestorage tank to tissue at a lower pressure suitable for the application.The fluid should be applied at a consistent flow rate and at aconsistent pressure. In addition, medical fluid delivery systems oftenrequire multiple regulators to properly convert the high pressure fluidto a pressure suitable for application to tissue. Multiple regulatorsinhibit the ability to integrate the regulators with a fluid cylinder,are often costly, and make it difficult to integrate the regulator(s) ina hand-held device for ease of operation. Moreover, conventionalregulators include washers or O-rings that generate friction forces withthe regulator, making it difficult to dispense fluid at a consistentflow rate and at a consistent pressure. These drawbacks can prevent aproper amount of fluid and/or material from being expelled at a targetlocation, thereby decreasing the accuracy and increasing the time andcost of procedures using these conventional devices. Accordingly, it isdesirable to ensure that fluid, powder, and/or reagents are properly andconsistently dispensed to the target location. The present disclosuremay solve one or more of these problems or other problems in the art.The scope of the disclosure, however, is defined by the attached claimsand not the ability to solve a specific problem.

SUMMARY OF THE DISCLOSURE

According to an example, a medical device includes an application devicewith a first fluid path and a container movable attached to theapplication device. The container and the application device have asecond fluid path therethrough, the container includes an inner chamberthat is intermediate proximal and distal portions of the second fluidpath, the inner chamber is fluidly isolated from the distal portion ofthe second fluid path at a first position of the container, and theinner chamber is fluidly coupled to the proximal and distal portions ofthe second fluid path at a second position of the container. The firstfluid path bypasses the container and the passage of fluid through thefirst fluid path is separately controllable from the passage of fluidthrough the second fluid path.

The medical device further includes a second container having apropellant fluid and may be configured to be attached to an inlet of theapplication device.

The application device may further include a locking mechanism forsecuring the second container to the application device.

The locking mechanism may include a lever pivotally connected to theapplication device and a piston connected to the lever and contactingthe second container, such that in a first position of the lever, thesecond container may be fluidly decoupled from the application device,and in a second position of the lever, the second container may befluidly coupled to the application device.

A protrusion may extend from a surface of the piston toward the inlet,and a void may extend into the container from a surface facing thepiston. The protrusion may extend into the void to maintain a fixedposition of the container with respect to the piston.

The container may include a chamber inlet between the inner chamber andthe proximal portion of the second fluid path, and a chamber filter, thefilter may be configured to allow a fluid to enter the inner chamberfrom the proximal portion of the second fluid path, and the filter maybe configured to prevent a material disposed in the container fromentering the proximal portion of the second fluid path.

The inner chamber may include one or more protrusions extending from abottom surface of the inner chamber into the inner chamber, and the oneor more protrusions may be configured to change a fluid path of thepropellant fluid in the inner chamber.

The inner chamber may include a tube having an outlet port, and a sheathdisposed about the tube, such that the outlet port may be covered by thesheath when the container is at the first position, and the outlet portma be exposed from the sheath when the container is at the secondposition.

The inner chamber may include an attachment member fixedly attached tothe sheath and an outer surface of the container, and rotation of theouter surface causes the sheath to move longitudinally on the tube.

The application device may include includes a groove having a first endand a second end, the container may include a cam extending from theouter surface of the container, the cam may be movable within thegroove, wherein the cam may be disposed at the first end of the groovewhen the container is at the first position, and the cam may be disposedat the second end of the groove when the container is at the secondposition.

The application device may include first and second actuation devices,the first actuation device may be configured to control the propellantfluid in the first fluid path, and the second actuation device my beconfigured to control the propellant fluid in the second fluid path.

The second fluid path may include a pressure release mechanismconfigured to release fluid when a pressure of a fluid in the secondfluid path is greater than a threshold, and the threshold may be greaterthan a desired pressure of a fluid at an outlet of the second fluidpath.

The pressure release mechanism may include a burst disc and may bedisposed in the inner chamber of the container.

The inlet of the application device includes a second pressure releasemechanism, and actuation of the second pressure release mechanism mayrelease the propellant fluid from the second container.

A catheter may be attached to an outlet of the distal portion of thesecond fluid path via a luer connection.

According to another example, a medical device includes an applicationdevice having a first fluid path therethrough, and a container movablyattached to the application device, the container and the applicationdevice have a second fluid path therethrough, the container has an innerchamber having an inlet configured to be fluidly coupled to a proximalportion of the second fluid path and an outlet configured to be fluidlycoupled to a distal portion of the second fluid path, the containerincludes a filter configured to prevent a material provided in thecontainer from entering the proximal portion of the first fluid path,and the inner chamber is fluidly decoupled from the proximal portion ofthe second fluid path when the container is at a first position, and theinner chamber is fluidly coupled to the proximal and distal portions ofthe second fluid path when the container is at a second position.

The inner chamber may include a tube having an outlet port, and a sheathdisposed about the tube, the outlet port may be covered by the sheathwhen the container is at the first position, and the outlet port may beexposed from the sheath when the container is at the second position.

The application device may include a groove having a first end and asecond end, the container may include a cam extending from an outersurface of the container, the cam may be within the groove, the cam maybe disposed at the first end of the groove when the container is at thefirst position, and the cam may be disposed at the second end of thegroove when the container is at the second position.

According to yet another example, a medical device includes anapplication device having a first fluid path, an inlet, and an outlet,and a container attached to the application device, the container andthe application device have a second fluid path therethrough, thecontainer includes an inner chamber between distal and proximal portionsof the second fluid path, the inner chamber includes an inflowconfigured to be fluidly coupled to the proximal portion of the secondfluid path and an outflow configured to be fluidly coupled to the distalportion of the second fluid path, and the inner chamber includes atleast one protrusion extending into the inner chamber. Fluid in thefirst fluid path travels from the inlet to the outlet, bypassing thecontainer, and the second fluid path includes a relief valve configuredto release a fluid from the second fluid path when a pressure within thesecond fluid path is greater than a threshold.

The medical device may further include a second container including apropellant fluid, and a locking mechanism, wherein the locking mechanismmay include a lever pivotally connected to the application device, apiston connected to the lever and contacting the second container, in afirst position of the lever, the second container may be fluidlydecoupled from the application device, and in a second position of thelever, the second container may be fluid coupled to the applicationdevice.

In yet another aspect, a device for regulating pressure of a fluidincludes a body having an input opening for receiving the fluid, anoutput opening for delivering the fluid, and a chamber in fluidcommunication with and between the input opening and the output opening.The chamber defines a chamber opening, a flexible membrane contactingthe body and having a first surface sealingly covering the chamberopening, and a piston adjacent a second surface of the membrane oppositethe first surface for regulating a position of the membrane to regulatepressure of the fluid.

The device may include a pierce pin within the chamber adjacent theinput opening and configured to pierce a seal of a containment deviceconfigured to contain the fluid.

The body may include a protrusion extending into the chamber anddividing the chamber into a first chamber adjacent the input opening andan annular chamber adjacent the output opening, the device may includean actuator surrounding at least a portion of the protrusion andcontacting the first surface of the membrane.

The protrusion may include a first hole fluidly connecting the firstchamber with the annular chamber, and a prong of the actuator may extendinto the first hole.

The device may include a first spring disposed in the first chamber andconfigured to push a ball bearing toward the first hole.

The device may include an O-ring provided between the ball bearing andthe first hole.

A wall of the actuator may include a second hole in fluid communicationwith and between the annular chamber and the first chamber.

The device may include a capture member having a first end attached tothe body and a second end defining a capture member chamber in which thepiston is movably contained, and a cap may be attached to the capturemember adjacent the second end to cover an opening of the capturemember.

The membrane may be fixed between the body and the capture member.

The device may include a second spring disposed between the piston andthe cap and configured to force the piston toward the membrane.

The annular chamber may not include an O-ring.

A fluid path may extend from the input opening, through the firstchamber, through the first hole, through the annular chamber, and outthe output opening.

The device may include an O-ring disposed in the first chamber adjacentto the first hole, a ball bearing may be disposed in the first chamberadjacent the O-ring on a side opposite the first hole, and a spring maybe provided in the first chamber contacting the ball bearing and thepierce pin and configured to urge the ball bearing toward the O-ring.

The device may include a first hole in the protrusion fluidly connectingthe first chamber with the annular chamber, an O-ring may be disposed inthe first chamber adjacent to the first hole, and a poppet may include abody portion disposed in the first chamber, having an annular ringsurrounding the body and adjacent the O-ring on a side opposite thefirst hole, and the poppet may include an elongated member extendingfrom the body portion, perpendicular to the annular ring, through theO-ring and a hole, and contacting the body.

According to another aspect, a delivery system for dispensing fluidincludes a containment device configured to contain the fluid, and anapplication device connected to the containment device and configured todispense the fluid, the application device comprising an inletconfigured to be connected to the containment device to receive thefluid from the containment device, and a regulator in fluidcommunication with the inlet and configured to regulate the release ofthe fluid. The regulator includes a body having an input opening forreceiving the fluid, an output opening for delivering the fluid, and achamber in fluid communication with the input opening and the outputopening, the chamber defines a chamber opening, a flexible membranecontacting the body and having a first surface sealingly covering thechamber opening, and a piston adjacent a second surface of the membraneopposite the first surface and configured to regulate a position of themembrane to regulate pressure of the fluid.

The system may include a piston chamber defined between and withinannular walls of the piston, and a spring may be disposed in the pistonchamber and configured to push the piston against the membrane.

The system may include an actuating device, and the fluid configured tobe dispensed from the application device upon actuation of the actuatingdevice

In yet another aspect, a method for controlling a fluid delivery to abody of a patient includes moving a piston and a flexible membrane of aregulator toward an input opening of the regulator, the input openingreceiving the fluid from a containment device, contacting an actuator ofthe regulator with the membrane to open a fluid pathway from the inputopening to an output opening of the regulator, and causing a fluid to bereleased.

The method may include compressing a spring adjacent the input opening;and breaking a fluid seal between the input opening and the output toopen the fluid pathway between the input opening and the output openingof the regulator.

According to another aspect, a device configured to regulate pressure ofa fluid includes a first body having an input opening for receiving thefluid, an output opening for delivering the fluid, wherein the firstbody includes a protrusion extending into the chamber and dividing thechamber into a first chamber adjacent the input opening and a secondchamber adjacent the output opening, and wherein the protrusion includesa hole fluidly connecting the first chamber and the second chamber, anX-ring disposed in the first chamber adjacent to the hole, and a secondbody disposed in the first chamber adjacent the X-ring on a sideopposite the hole.

The protrusion may have a first surface and a second surfaceapproximately perpendicular to the first surface, wherein each of thefirst surface and the second surface may face the first chamber.

The X-ring may contact two separated portions of at least one of thefirst surface and the second surface.

The X-ring may contact two separated portions of each of the firstsurface and the second surface.

The X-ring may include four protrusions, and the second body may beconfigured to contact one of the four protrusions in at least one stateof the device.

The X-ring and the second body may be configured to prevent fluid frompassing through the hole in at least one state of the device.

The device may further include a first spring disposed in the firstchamber and configured to push the second body toward the hole.

A fluid path may extend from the input opening, through the firstchamber, through the hole, through the second chamber, and out theoutput opening.

The second chamber may define a chamber opening, and the device mayfurther include a flexible membrane contacting the body and having afirst surface sealingly covering the chamber opening.

The device may further include an actuator surrounding at least aportion of the protrusion and contacting the first surface of themembrane.

The device may further include a piston adjacent a second surface of themembrane opposite the first surface and configured to regulate aposition of the membrane.

The device may further include a second spring disposed between thepiston and a cap and configured to force the piston toward the membrane.

The second body may include rubber.

The X-ring may include silicone.

Properties of the second body and X-ring may be such that the secondbody and X-ring are compatible with temperatures of −50 C.

According to another aspect, a device is configured to regulate pressureof a fluid, the device includes a first body having an input opening forreceiving the fluid, an output opening for delivering the fluid, and achamber between the input opening and the output opening, wherein thechamber defines a chamber opening, a flexible membrane contacting thefirst body and having a first surface sealingly covering the chamberopening, an X-ring disposed in the chamber, a second body disposed inthe chamber adjacent the X-ring, and a spring provided in the chamberscontacting the second body and configured to urge the second body towardthe X-ring.

The chamber may at least partially defined by a first surface and asecond surface, and wherein the X-ring may contact two separatedportions of at least one of the first surface and the second surface.

The X-ring may include four protrusions, and the second body may beconfigured to contact one of the four protrusions in at least one stateof the device.

According to an aspect, a device may be configured to regulate pressureof a fluid, and the device may include a first body having an inputopening for receiving the fluid, an output opening for delivering thefluid, and a chamber in fluid communication with and between the inputopening and the output opening, an X-ring disposed in the chamber, asecond body disposed in the chamber adjacent the X-ring, a first springprovided in the chamber, contacting the second body, and configured tourge the second body in a first direction, toward the X-ring, a piston,and a second spring configured to push the piston in a second direction,opposite the first direction, toward the X-ring.

The chamber may at least partially defined by a first surface and asecond surface, and wherein the X-ring may contact two separatedportions of at least one of the first surface and the second surface.

According to another aspect, a device for fluidizing and delivering apowdered agent comprises a canister extending longitudinally from afirst end to a second end and defining an interior space within which apowdered agent is received, an inlet coupleable to a gas source forsupplying gas to the interior space to fluidize the powdered agentreceived therewithin to create a fluidized mixture, an outlet via whichthe gas mixture is delivered to a target area for treatment, a tubeextending from a first end in communication with the outlet to a secondend extending into the interior space, the tube including a slotextending through a wall thereof so that gas mixture is passable fromthe interior space through the outlet via the second end and the slot,and a door movably coupled to the tube so that the door is movable overthe slot to control a size of the slot open to the interior space of thecanister.

In an aspect, the door may be configured as an overtube movably mountedover the tube.

In an aspect, the device may further comprise a stabilizing ringextending radially outward from the overtube to an interior surface ofthe canister to fix the tube relative to the canister.

In an aspect, the canister may be rotatable relative to the tube to movethe overtube longitudinally relative to the tube and control the size ofthe slot open to the interior space.

In an aspect, the device may further comprise a lid coupleable to thecanister to enclose the interior space, the inlet and the outletconfigured as openings extending through the lid.

In an aspect, the device may further comprise a delivery cathetercoupleable to the outlet, the delivery catheter sized and shaped to beinserted through a working channel of an endoscope to the target area.

The present aspects are also directed to a device for fluidizing anddelivering a powdered agent, comprising a canister extendinglongitudinally from a first end to a second end and including a firstinterior space within which a powdered agent is received, a first inletcoupleable to a gas source for supplying gas to the interior space tofluidize the powdered agent received therewithin to create a fluidizedmixture, an outlet via which the gas mixture is delivered to a targetarea for treatment from the first interior space, and a filler chamberin communication with the first interior space via a filler inlet, thefiller chamber containing a filler material passable from the fillerchamber to the first interior space to maintain a substantially constantvolume of material therein, wherein the material includes at least oneof the powdered agent and the filler material.

In an aspect, the filler material may include one of mock particles,beads, bounce balls, and a foam material.

In an aspect, the filler material may be sized, shaped and configured sothat the filler material cannot be passed through the outlet.

In an aspect, the filler chamber may be supplied with a gas to drive thefiller material from the filler chamber into the first interior space.

In an aspect, the filler chamber may be configured as a second interiorspace defined via the canister.

In an aspect, the second interior space may include an angled surfacedirecting the filler material to the filler inlet.

In an aspect, the filler material may be additional powdered agent.

In an aspect, the device may further comprise a door movable relative tothe filler inlet between a first configuration, in which the door coversthe filler inlet, to a second position, in which the door opens thefiller inlet to permit filler material to pass therethrough from thefiller chamber to the first interior space via gravity.

In an aspect, the device may further comprise a turbine connected to apaddle housed within the filler inlet, the turbine driven by a flow ofgas so that, when a flow of gas is received within a flow path housingthe turbine, the turbine rotates to correspondingly rotate the paddle sothat filler material within the filler chamber is actively driventherefrom and into the first interior space.

The present aspects are also directed to a method, comprising supplyinga gas to an interior space within a canister within which a powderedagent is received to fluidize the powdered agent, forming a fluidizedmixture and delivering the fluidized mixture to a target area within apatient body via a delivery catheter inserted through a working channelof an endoscope to the target area, wherein during delivery of thefluidized mixture, a door movably mounted over the tube is movedrelative to a slot extending through a wall of a tube extending into theinterior space of the canister in communication with the deliverycatheter, to control a size or a portion of the slot exposed to theinterior space.

The present aspects are also directed to a device for fluidizing anddelivering a powdered agent, comprising a canister extendinglongitudinally from a first end to a second end and defining an interiorspace within which a powdered agent is received, an inlet coupleable toa gas source for supplying gas to the interior space to fluidize thepowdered agent received therewithin to create a fluidized mixture, anoutlet via which the gas mixture is delivered to a target area fortreatment, and a piston movably coupled to the canister, the pistonmovable from an initial configuration, in which the piston is coupled tothe first end of the canister, toward the second end of the canister toreduce a volume of the interior space as a volume of the powdered agentis reduced during delivery of the fluidized mixture to the target area.

In an aspect, each of the inlet and the outlet may extend through aportion of the piston.

In an aspect, the outlet may be coupleable to a delivery catheter sizedand shaped to be inserted through a working channel of an endoscope tothe target area.

In an aspect, the piston may be movable via one of a pneumatic cylinderand motor.

In an aspect, the device may further comprise a chamber connected to thefirst end on the canister on a side of the piston opposing the interiorspace of the canister, the chamber housing an expandable member which isconfigured to receive gas during delivery of the fluidized mixture sothat the expandable mixture expands to move the piston toward the secondend of the canister.

In an aspect, the expandable member may be configured to be connected tothe gas source via a connecting member including a one way valve whichpermits a flow of gas into the expandable member while preventing a flowof gas out of the expandable member.

In an aspect, the device may further comprise a bypass connected to thefirst end of the canister and coupled to the piston via a threaded rod,the bypass housing a turbine connected to the threaded rod and beingconfigured to receive a flow of gas therethrough so that, when gas flowsthrough the bypass during delivery of the fluidized mixture, the turbineand threaded rod rotate to move the piston toward the second end of thecanister.

The present aspects are directed to a device for fluidizing anddelivering a powdered agent, comprising a canister extendinglongitudinally from a first end to a second end and including a firstinterior space within which a powdered agent is received, an inletcoupleable to a gas source for supplying gas to the interior space tofluidize the powdered agent received therewithin to create a fluidizedmixture, an outlet via which the gas mixture is delivered to a targetarea for treatment, and an expandable member movable between an initialbiased configuration and an expanded configuration in which theexpandable member is deformed so that a portion of the expandable memberextends into the first interior space to reduce a volume thereof as avolume of the powdered agent therein is reduced during delivery of thefluidized mixture to the target area.

In an aspect, the canister may further include a second interior spaceconfigured to receive a gas therein during delivery of the fluidizedmixture to the target area.

In an aspect, the first and second interior spaces may be separated fromone another via an expandable member, a pressure differential betweenthe first and second interior spaces causing the expandable member todeform into the first interior space.

In an aspect, the expandable member may be a diaphragm.

In an aspect, the first interior space may be defined via an interiorwall of the expandable member and the second interior space may bedefined via an exterior wall of the expandable member and an interiorsurface of the canister.

In an aspect, the expandable member may be substantially cylindricallyshaped.

In an aspect, the expandable member may extend from the first end of thecanister to the second end of the canister.

In an aspect, the expandable member may be a balloon housed within thecanister and configured to receive a gas therewithin so that, as theballoon is inflated, the balloon fills the first interior space.

The present aspects are also directed to a method, comprising supplyinga gas to an interior space within a canister within which a powderedagent is received to fluidize the powdered agent, forming a fluidizedmixture, and delivering the fluidized mixture to a target area within apatient body via a delivery catheter inserted through a working channelof an endoscope to the target area, wherein during delivery of thefluidized mixture, a volume of the interior space of the canister isreduced to correspond to a reduction in volume of the powdered agent sothat a rate of delivery of the fluidized mixture remains substantiallyconstant.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate various exemplary embodiments andtogether with the description, serve to explain the principles of thedisclosed embodiments.

FIG. 1 is a perspective view of a medical system according to anembodiment;

FIG. 2 is a cross-section of an applicator handle of the medical systemof FIG. 1 ;

FIG. 3 is a perspective view of a flow path of the medical system ofFIG. 1 ;

FIG. 4 is a perspective view of a locking mechanism of the medicalsystem of FIG. 1 ;

FIG. 5 is a cross-section of the applicator handle of FIG. 3 including aregulator according to an embodiment;

FIGS. 6A-6C are cross-sections of a regulator according to anembodiment;

FIG. 7 is a cross-section of a regulator according to anotherembodiment;

FIG. 8 is a perspective view of a regulator according to an embodiment;

FIG. 9 is a perspective view of a body of a regulator according to anembodiment;

FIG. 10 is a perspective view of a capture cylinder of a regulatoraccording to an embodiment;

FIGS. 11A and 11B are cross-sections of a regulator according to stillanother embodiment;

FIG. 12 is a perspective view of a portion of the medical system of FIG.1 ;

FIG. 13 is a perspective view of a chamber of the medical system of FIG.1 ;

FIGS. 14A and 14B are perspective views of the chamber of FIG. 13 ;

FIG. 15 shows a schematic view of a chamber according to anotherembodiment, in a first configuration;

FIG. 16 shows a perspective view of the device of FIG. 15 , in a secondconfiguration;

FIG. 17 shows a schematic view of a device according to anotherembodiment of the present disclosure;

FIG. 18 shows a schematic view of a device according to an alternateembodiment of the present disclosure;

FIG. 19 shows a schematic view of a device according to yet anotherembodiment of the present disclosure;

FIG. 20 shows a lateral cross-sectional view of the device of FIG. 19along the line 19-19;

FIG. 21 shows a schematic view of a device according to anotherembodiment of the present disclosure;

FIG. 22 shows a schematic view of a device according to yet anotherembodiment of the present disclosure, in a first configuration;

FIG. 23 shows a schematic view of the device of FIG. 22 , in a secondconfiguration;

FIG. 24 shows a schematic view of a device according to an alternateembodiment of the present disclosure, in a first configuration;

FIG. 25 shows a schematic view of the device of FIG. 24 , in a secondconfiguration;

FIG. 26 shows a schematic view of a device according to an embodiment ofthe present disclosure;

FIG. 27 shows a schematic view of a device according to an alternateembodiment of the present disclosure;

FIG. 28 shows a schematic view of a device according to anotheralternate embodiment of the present disclosure;

FIG. 29 shows a bottom view of the device according to FIG. 28 ;

FIG. 30 shows a schematic view of a device according to anotherembodiment of the present disclosure;

FIG. 31 shows a schematic view of a device according to yet anotherembodiment of the present disclosure;

FIG. 32 shows a schematic view of a device according to anotherembodiment;

FIG. 33 shows a schematic view of device according to yet anotherembodiment of the present disclosure;

FIG. 34 shows a schematic view of a device according to an alternate ofthe present disclosure; and

FIG. 35 is a perspective view of a catheter of the medical device ofFIG. 1 .

DETAILED DESCRIPTION

The present disclosure is now described with reference to exemplarymedical devices that may be used in dispensing materials. However, itshould be noted that reference to any particular procedure is providedonly for convenience and not intended to limit the disclosure. A personof ordinary skill in the art would recognize that the conceptsunderlying the disclosed devices and application methods may be utilizedin any suitable procedure, medical or otherwise. The present disclosuremay be understood with reference to the following description and theappended drawings, wherein like elements are referred to with the samereference numerals.

For ease of description, portions/regions/ends of a device and/or itscomponents are referred to as proximal and distal ends/regions. Itshould be noted that the term “proximal,” as it relates to anapplication device, is intended to refer to ends/regions closer to aninlet of a propellant gas to the application device (e.g., at a locationof the application device where the propellant gas is released from acontainment device into the application device), and the term “distal,”as it relates to an application device, is used herein to refer toends/regions where the propellant gas and/or any material is releasedfrom the application device to a target area or, if a catheter isattached to the application device, from the catheter to the targetarea. Similarly, extends “distally” indicates that a component extendsin a distal direction, and extends “proximally” indicates that acomponent extends in a proximal direction. Both the foregoing generaldescription and the following detailed description are exemplary andexplanatory only and are not restrictive of the features, as claimed. Asused herein, the terms “comprises,” “comprising,” “having,” “including,”or other variations thereof, are intended to cover a non-exclusiveinclusion such that a process, method, article, or apparatus thatcomprises a list of elements does not include only those elements, butmay include other elements not expressly listed or inherent to such aprocess, method, article, or apparatus. In this disclosure, relativeterms, such as, for example, “about,” “substantially,” “generally,” and“approximately” are used to indicate a possible variation of ±10% in astated value or characteristic.

Referring to FIG. 1 , a medical system, e.g., a delivery system, 10according to an embodiment is shown. Delivery system 10 includes acontainment device 20 and an application device 30, e.g., a hand-helddevice, connected thereto by a conduit 22. As will be described herein,application device 30 may be attached directly to, or otherwise beintegrated with, containment device 20 without conduit 22 therebetween(see e.g., FIG. 2 ). As further shown in FIGS. 1-3 , application device30 includes an inlet 32, an outlet 34, and actuating devices 36 a, 36 b.According to an example, outlet 34 may be a male or a female luerfitting, but is not limited to this configuration. As will be explainedherein, the propellant fluid and/or any additional material is expelledinto catheter 190 via outlet 34, allowing a user to output thepropellant fluid at a desired location. Examples of apparatuses fordelivering powdered agents are found in U.S. patent application Ser. No.16/259,024, entitled “Apparatuses and Methods for Delivering PowderedAgents,” and filed on Jan. 28, 2019, the complete disclosure of which isincorporated by reference herein.

With reference to FIG. 1 , containment device 20 is configured tocontain a fluid, such as a gas, e.g., carbon dioxide or any other gas offluid known in the art. While shown as a box, containment device 20 maybe any shape, such as a torpedo-shape (see e.g., FIG. 2 ), a sphere, orany other shape known in the art for containing gas. For example,containment device 20 could be a carbon dioxide tank or cylindertypically formed in medical settings, such as a hospital. Containmentdevice 20 includes one or more outer walls defining one or more innerchambers (not shown), the inner chamber(s) configured to contain thefluid. The walls of containment device 20 may be formed of any materialsuitable for containing the fluid, such as but not limited to a metalalloy, a ceramic, or other material known in the art. The fluidcontained in the inner chamber of containment device 20 may be underpressure. Accordingly, the walls are formed of a material and/or athickness suitable to contain the fluid at a pressure of, for example,at least approximately 1000 pounds per square inch (PSI), orapproximately 850 PSI. For example, gases which may be contained incontainment device 20 include carbon dioxide (CO₂) having a vaporpressure of approximately 2,000-8,000 kPa at typical devicetemperatures, or nitrogen (N2) having a vapor pressure less than 40 MPaat typical device temperatures. It will be understood that these gasesare examples and are not limiting to the types of gases contained incontainment device 20.

With continued reference to FIG. 1 , application device 30 is attachedto containment device 20 via conduit 22. Conduit 22 may supply fluidunder pressure from containment device 20 to application device 30. Aswill be described in greater detail herein, actuation of actuatingdevices 36 a, 36 b causes fluid to move from containment device 20,through conduit 22, and to application device 30, allowing a user tooutput the fluid at a desired location via catheter 190. Conduit 22 maybe made of any material, for example reinforced rubber or a suitableplastic, that allows conduit 22 to withstand the pressures of the fluid,while simultaneously allowing for unrestricted movement of conduit 22.Conduit 22 may be attached to containment device 20 and applicationdevice 30 by any attachment device, including but not limited toscrew-type connectors, pressure washer adapters, or any other deviceknown in the art.

According to another embodiment, application device 30 may be connecteddirectly to containment device 20′, without any intervening structure,as shown in FIG. 2 . For example, inlet 32 may be connected directly toan output, such as a protuberance of containment device 20′ using athreaded connection, pressure washer adapter, or the like. Theprotuberance of containment device 20′ may extend into inlet 32 ofapplication device 30 and connect, directly or via an interveningstructure, e.g., a lumen, to a regulator 40. Directly connectingapplication device 30 to containment device 20′ may be suitable for,e.g., a small-volume containment device 20′ containing approximately 5 gto 75 g of compressed gas, or preferably approximately 12 g to 40 g ofcompressed gas, to allow for greater portability of delivery system 10.

Referring to FIG. 1 , actuation of actuating devices 36 a, 36 b ofapplication device 30 causes the fluid to exit delivery system 10through outlet 34 of application device 30. It will be understood thatonly one actuating device 36 a, 36 b may need to be actuated in someembodiments. Alternatively, or additionally, a plurality of actuatingdevices 36 a, 36 b may be simultaneously actuated to release fluid as,for example, a safety precaution. As will be described herein, actuationof actuating device 36 a, 36 b releases a buildup of pressure withindelivery system 10, causing regulator 40 to release fluid fromcontainment device 20′ at a predetermined pressure. Application device30 may be, e.g., a handle such as a garden-hose handle or otherpistol-like configuration. Actuating device 36 a, 36 b may be any pushbutton, trigger mechanism, or other device that, when actuated, opens avalve and releases fluid, as will be described in greater detail herein.

With reference to FIG. 2 , application device 30 is attached directly toa torpedo-shaped containment device 20′, without any interveningstructure. Containment device 20′ may be attached to inlet 32 ofapplication device 30 by any attachment device 38, including but notlimited to screw-type connectors, pressure washer adapters, a pierce pinand seal arrangement, or any other device known in the art. It will alsobe understood that attachment device 38, or any other device forattaching containment device 20′ to application device 30, may includean actuator 39 (e.g., a tab, a button, etc.) for opening or rupturing aburst disc or pressure release valve attached to containment device 20′and/or application device 30. Actuator 39 may be actuated at an end of aprocedure to vent any remaining propellant fluid from containment device30. An alert, such as a tactile or an audible alert, may be generatedwhen containment device 20′ is attached to application device 30.Alternatively, containment device 20′ may be attached to applicationdevice 30 by a locking mechanism 50, as will be described in greaterdetail below. Additionally, a cap 150 may be attached by screw fit, snapfit, or any other attachment mechanism to a handle 31 of applicationdevice 30. For example, cap 150 may be attached to an end of handle 31opposite attachment device 38. Cap 150 may provide additional support tosecure containment device 20′ to application device 30.

As discussed above, one or more regulators 40 may assist in regulatingan amount of propellant fluid released from containment device 20′ at aspecific pressure, as will be described in greater detail with referenceto FIGS. 5-11B. For example, regulator 40 may be a dual stage regulator,or regulator 40 may be two single stage regulators, such as two pistonregulators, aligned in series. As will be discussed in greater detailbelow, regulator 40 may include a pierce pin 670 (see FIG. 6A) to piercea seal of containment device 20′ when containment device 20′ is attachedto application device 30. Alternatively, a separate device, such as apierce pin or other mechanism for rupturing a seal of containment device20′, may be provided at inlet 32 of application device 30. Further,inlet 32 may provide an all-or-nothing scenario in which the containmentdevice 20′ is completely attached or completely detached fromapplication device 30 using, e.g., gaskets or washers (not shown) toprevent leakage at inlet 32. A propellant fluid pressure may further beadjusted by a membrane regulator 44 provided in series after regulator40. The combination of regulator 40 and membrane regulator 44 may reducethe pressure of gas from containment device 20′ to an acceptable outletpressure, i.e., a pressure of the gas and any material at outlet 34. Apressure of a gas within delivery system 10, after regulators 40, 44,and at a target area in a patient, may be predetermined, based on thetissue to which the gas and material is being dispensed. An acceptablepressure at outlet 34 may be approximately plus or minus 40% deviationfrom the target pressure, more preferably approximately plus or minus25% deviation from the target pressure. For example, regulator 40 mayreduce inlet pressure of the dispensing propellant fluid toapproximately 50-150 PSI, and membrane regulator 44 may subsequentlyreduce the propellant fluid to approximately 20-50 PSI. According to anexample, regulator 40 and membrane regulator 44 reduce the propellantfluid to the desired output pressure of the propellant fluid based on apredetermined setting during manufacturing. Alternatively, oradditionally, one or both of regulator 40 and membrane regulator 44 mayinclude a mechanism (not shown) for adjusting the pressure of thepropellant fluid output from each regulator. Further, the pressure ofthe propellant fluid at an outlet of membrane regulator 44 may beapproximately equal to the pressure of the propellant fluid at outlet34. Alternatively, the pressure of the propellant fluid at outlet 34 maybe different from the pressure of the propellant fluid at the outlet ofmembrane regulator 44.

With reference to FIGS. 2 and 3 , two fluid paths diverge at aY-connector 45, which is just distal to an outlet of membrane regulator44. A first fluid path 46, which may be a purge path and which maybypass a material-containing container, may be controlled by actuatingdevice 36 b. For example, first fluid path 46 may bypass a container 100to release propellant fluid from membrane regulator 44 directly tooutlet 34. First fluid path 46 allows propellant fluid from containmentdevice 20′ to purge catheter 190 to remove any debris provided therein.A second fluid path 48 may be controlled by actuating device 36 a todirect propellant fluid from membrane regulator 44, through container100, to outlet 34. Second fluid path 48 allows the propellant fluid toenter container 100, which contains powder or other material to bedispensed as discussed in greater detail below, mix with the powder ormaterial contained therein, and transport the mixture through outlet 34to a target site, via catheter 190. According to an example, propellantfluid travels through first fluid path 46 at approximately 8-12 standardliters per minute (SLPM), or preferably approximately 10 SLPM.Alternatively, propellant fluid may travel through first fluid path 46at approximately 4-6 SLPM, or preferably approximately 5 SLPM.Propellant fluid travels through second fluid path 48 at approximately0.5-4.5 SLPM, or preferably approximately 2 SLPM.

Flow paths of propellant fluid, including fluid paths 46 and 48, areshown in FIG. 3 . Propellant fluid flows along first pathway J fromregulator 40, through membrane regulator 44, and to a junction of firstfluid path 46 and second fluid path 48. At the junction of first fluidpath 46 and second fluid path 48, pathway J splits into second pathway Kand third pathway M. Second pathway K travels along first fluid path 46to second actuating device 36 b. When actuated, second actuating device36 b dispenses dispensing fluid along fourth pathway L (distal to secondactuating device 36 b), which terminates at outlet 34. First pathway J,second pathway K, and fourth pathway L form first fluid path 46.Alternatively, propellant fluid from first pathway J may follow thirdpathway M to first actuating device 36 a. When actuated, first actuatingdevice 36 a dispenses propellant fluid along fifth pathway N (distal tofirst actuating device 36 a) and each of a plurality of sixth pathwaysO, which provide propellant fluid to container 100 through filter holes104 a (see FIG. 12 ). Propellant fluid mixes with material provided incontainer 100 (a housing 107 of container 100, as shown in FIG. 12 , isnot shown in FIG. 3 for ease of understanding), as will be describedherein, and the mixture travels from container 100 along seventh pathwayO′, which leads from an outlet (described below) of container 100 to achamber outlet 114 (see FIGS. 14A and 14B), and eighth pathway P, whichleads along chamber outlet 114 to outlet 34. First, third, fifth, sixth,seventh, and eighth pathways J, M, N, O, O′, P, respectively, formsecond fluid path 48. Further, first, third, and fifth pathways J, M,and N form a proximal portion of second fluid path 48, eighth pathway Pforms a distal portion of second fluid path 48, and sixth and seventhpathways O, O′ form an intermediate portion of second fluid path 48. Asshown in FIG. 3 , first-eighth pathways J-P are tubes or lumen extendingthrough and/or interconnecting elements of medical device 10. Thesetubes and/or lumen may be formed of medical grade plastic, metal,ceramic, or any other suitable material for moving propellant fluidand/or material throughout medical device 10.

A locking mechanism 50 for securing containment device 20′ will bedescribed with reference to FIG. 4 . Locking mechanism 50 may replacecap 150 in FIG. 2 . Locking mechanism 50 includes a lever 52 pivotallyconnected to handle 31 of application device 30 at pivot axis R. Lever52 includes a cam path 54 defining a curved path, and a locking notch 56at one end of the cam path 54. A pin 57 extends generally perpendicularfrom a shaft 60, and pin 57 rides along cam path 54 between lockingnotch 56 and an opposite end of cam path 54. Shaft 60 extends along alongitudinal axis of handle 31 and includes a piston head 58 attached toan end of shaft 60 opposite pin 57. As shown in FIG. 4 , a bottomsurface of containment device 20′ sits on a top surface of piston 58.Lever 52 is angled with respect to handle 31 when locking mechanism 50is unlocked, e.g., when introducing or removing containment device 20′from handle 31. Lever 52 rotates about pivot axis R, causing pin 57 toride in cam path 54 from the first end to the locking notch 56. Pin 57locks in locking notch 56 when lever 52 is substantially parallel tohandle 31. The curvature of cam path 56 forces shaft 60 and piston 58against the bottom surface of containment device 20′, moving containmentdevice 20′ toward a pierce pin (not shown, see, e.g., pierce pin 670 inFIG. 6A), causing the pierce pin to rupture a seal (not shown) oncontainment device 20′ and fluidly connect containment device 20′ toapplication device 30. In one example, cavities 20 a extend into abottom surface of containment device 20′ and receive protrusions 58 aextending from a topmost surface of piston 58, thereby removablyconnecting containment device 20′ and piston 58, and preventingcontainment device 20′ from slipping with respect to piston 58.Alternatively, or additionally, the topmost surface of piston 58 and/orthe bottommost surface of containment device 20′ may include a texturedsurface, such as abrasions, knurls, cavities, slots, or any otherfriction-increasing coating to increase the friction between containmentdevice 20′ and piston 58 to maintain a relative position betweencontainment device 20′ and piston 58. This configuration may aidcontainment device 20′ to be properly urged toward the pierce pin and toproperly seal containment device 20′ to application device 30.

Referring to FIG. 5 , many elements of application device 30 arestripped away to show a position of regulator 40. It will be understoodthat the position of regulator 40 within application device 30 is onlymeant for example, and is not limited to that shown in FIG. 5 .

With reference to FIGS. 6A and 8 , regulator 40 according to anembodiment will be described. Regulator 40 includes a body 650(including an input opening 652 and an output opening 654, each forcommunication to external environment), a cap 700, and a capturecylinder 710 (e.g., capture member). A membrane 730 is provided betweena piston 690 and an actuator 680. As further shown in FIG. 6A, regulator40 includes a pierce pin 670, first and second springs 740, 742, a ballbearing 750 (or another type of body), and an O-ring 760.

With reference to FIGS. 6A and 9 , body 650 of regulator 40 is generallycylindrical and has a central axis A. Body 650 includes a regulator wall656, and a first chamber 658 (adjacent input opening 652) and a secondchamber 660, each defined within regulator wall 656. Regulator wall 656may include screw threads on a radially-outer surface of wall 656 forattachment to additional structures, as discussed herein. An innerdiameter of regulator wall 656 in first chamber 658 is smaller than aninner diameter of regulator wall 656 in second chamber 660. Acylindrical protrusion 662 extends into second chamber 660, cylindricalprotrusion 662 having a hole 664 at it upper end, transverse to andcoaxial with central axis A. Hole 664 is in fluid communication with athird chamber 666, defined by an inner wall 662 a of cylindricalprotrusion 662. Third chamber 666 is in fluid communication with, andbetween, first chamber 658 and second chamber 660. According to anembodiment, there is no O-ring or other sealing member provided insecond chamber 660, thereby eliminating friction forces at and betweenregulator wall 656 and actuator 680 during movement of actuator 680.Additionally, body 650 may be any material known in the art, includingbut not limited to a metal alloy, a ceramic, and/or a resin.

As shown in FIG. 6A, O-ring 760 is disposed adjacent to inner wall 662a, within third chamber 666, and lies adjacent to hole 664. Ball bearing750 is adjacent to O-ring 760 on a side opposite hole 664. As will bedescribed herein, ball bearing 750 and O-ring 760 are capable of sealinghole 664 from communication with third chamber 666. Second spring 742 isdisposed in third chamber 666 between, and in contact with both of,pierce pin 670 and ball bearing 750. Second spring 742 is sized to havean outer diameter smaller than a diameter of inner wall 662 a, such thatsecond spring 742 can expand and contract without creating frictionforces between it and inner wall 662 a. O-ring 760 and ball bearing 750are sized such that an outer diameter of each is less than the innerdiameter of inner wall 662 a. In that way, when O-ring 760 and/or ballbearing 750 are not sealing hole 664, fluid flows within chamber 666,between inner wall 662 a and ball bearing 750, within and/or aroundO-ring 760, and through hole 664 to chamber 660. According to anexample, a seal effective diameter where ball bearing 750 seals againstO-ring 760 is approximately 0.05 inches to 0.14 inches, and preferablyapproximately 0.08 inches to 0.11 inches.

With continued reference to FIG. 6A, first chamber 658 is in fluidcommunication with third chamber 666, via a pierce pin chamber 676within pierce pin 670. First chamber 658 includes an area having a firstdiameter (defined by wall surface 656 a) and an area having a second,smaller diameter (defined by wall surface 656 b). Surfaces of firstchamber 658 may include threads (not shown) to accommodate componentswhich may be used to pierce containment device 20′. Alternatively,threads of surfaces of first chamber 658 may accommodate a threadedcontainment device 20′. For example, when containment device 20′ isscrewed into first chamber 658 (using, e.g., threads), pierce pin 670may pierce containment device 20′. Third chamber 666 is adjacent to, andhas a smaller diameter than, the second diameter area of chamber 658.The confluence of the second diameter area of chamber 658 and thirdchamber 666 defines a notch 668 outside and along a perimeter of thirdchamber 666. Notch 668, at its top, defines an annular flanged surface668 a.

Pierce pin 670 is shown in FIG. 6A. According to an embodiment, piercepin 670 may be disposed in notch 668 and abut flanged surface 668 a.According to an embodiment, pierce pin 670 may have an outer diameterequal to an inner diameter of the second diameter area of chamber 658.Pierce pin 670 includes a body portion 672 and a protrusion 674extending from body portion 672 into chamber 658, pierce pin 670 definespierce pin chamber 676 open at both ends, and extending through body 672and protrusion 674. First chamber 658 may be in fluid communication withpierce pin chamber 676 via opening 675. A first portion of chamber 676adjacent to chamber 666 has a larger diameter than a second portion ofchamber 676 adjacent to chamber 658. According to an embodiment,protrusion 674 includes an end wall 674 a angled relative to centralaxis A, preferably not perpendicular to central axis A. Pierce pin 670may be fixed to body 650 by, for example, adhesive, friction betweenbody 650 and pierce pin 670, welding, threads, etc. Additionally, oralternatively, pierce pin 670 may be formed as a single structure withbody 650 through, for example, additive manufacturing. Pierce pin 670may have any suitable geometry, including, for example, an arrow shape(not shown). In such a configuration, instead of having a protrusion674, surfaces of pierce pin 670 may slope radially outwardly from anarrow portion proximate to opening 675. The sloped surfaces mayterminate in a shoulder portion and include a stem extending from theshoulder portion, into third chamber 666. An arrow-shaped pierce pin 670may facilitate forming a relatively large hole in containment device20′. Air may flow through opening 675 and the stem portion, into thirdchamber 666.

According to an embodiment, protrusion 674 of pierce pin 670 pierces agasket of containment device 620 or conduit 622. Alternatively, oradditionally, protrusion 674 interacts with a device (not shown) oncontainment device 20′ or conduit 22, such as locking with the device,providing a fluid connection between regulator 40 and containment device20′ or conduit 22. According to an embodiment, pierce pin 670 may be anymaterial known in the art, including but not limited to a metal alloy, aceramic, and/or a resin.

FIG. 6A further illustrates actuator 680, which is a cylindrical memberhaving an outer actuator wall 682 and a top wall 683 defining anactuator chamber 684. Actuator chamber 684 is open at one end ofactuator 680, the end facing the bottom of FIG. 6A opposite top wall683. According to an embodiment and as shown in FIG. 6A, actuator 680may include a throughhole 686 in actuator wall 682 near top wall 683, aswill be described in greater detail herein. According to an embodiment,a central axis of though hole 686 is perpendicular to a prong 688.Additionally, as shown in FIG. 6A, prong 688 may extend from top wall683 into chamber 684. Prong 688 may be perpendicular to top wall 683,extending along central axis A into through hole 664 and into chamber666. When assembled, actuator 680 is provided in second chamber 660 andannularly surrounds at least a portion of cylindrical protrusion 662.Actuator 680 and cylindrical protrusion 662 are sized such that an outerwall 662 b of cylindrical protrusion 662 has a diameter smaller than adiameter of an inner wall 680 a of actuator 680, thereby forming anannular space 665 between actuator 680 and cylindrical protrusion 662.In this way, actuator 680 can slide (translate) along central axis A andfluid can flow between actuator 680 and cylindrical protrusion 662 inspace 665. According to an embodiment, actuator 680 may be any materialknown in the art, including but not limited to a metal alloy, a ceramic,and/or a resin.

With continued reference to FIG. 6A, piston 690 is generally cylindricalin shape, including an outer piston wall 692 and a bottom wall 693, aninner surface of piston wall 692 and an upper surface of wall 693defining a piston chamber 694, with piston chamber 694 being open at anupper end opposite wall 693. According to an embodiment, piston 690 maybe any material known in the art, including but not limited to a metalalloy, a ceramic, and/or a resin.

Cap 700 is also generally cylindrical in shape, having a cap outer wall702 and an upper cap wall 703, together defining a cap chamber 704,which is open at one end. Protuberance 706 extends from, and generallyperpendicular to, upper cap wall 703. As shown in FIG. 6A, spring 740 isprovided in piston chamber 694. A first end of spring 740 contacts aninner upper surface of piston wall 693. Spring 740 extends up to andencircles at least a portion of protuberance 706, such that an end ofspring 740 opposite the first end contacts an inner, lower surface ofupper cap wall 703. A hole (not shown) may be formed in upper cap 703above a protuberance chamber 707 formed by walls of protuberance 706,such that chamber 707 and piston chamber 694 may be in fluidcommunication with the atmosphere. Such a hole may relieve vacuum orpressure built up in piston chamber 694 as membrane 732 moves asdescribed below.

FIGS. 6 and 10 illustrate capture cylinder 710, which is generallycylindrical in shape. A first wall 712 defines a first chamber 716, anda second wall 714, connected by a step portion 720 to first wall 712,defines a second chamber 718. First chamber 716 and second chamber 718are fluidly connected, and capture cylinder 710 is open at the ends offirst chamber 716 and second chamber 718. According to an embodiment, adiameter of first chamber 716 is greater than a diameter of secondchamber 718; however, capture cylinder 710 is not limited to thisconfiguration. As shown in FIG. 6A, piston 690 rests inside secondchamber 718 such that the open end of piston chamber 694 and the openend of second chamber 718 face a same direction (the top of FIG. 6A).Piston 690 is sized and shaped to slide within second chamber 718, aswill be described in greater detail herein. For example, an outerdiameter of wall 692 a of piston 690 is smaller than a diameter of aninner wall 714 a of capture cylinder 710, thereby reducing and/oreliminating friction forces between piston 690 and capture cylinder 710.This reduced friction provides more freedom of movement betweenelements, thereby improving the consistency of the output pressure andflow rate of the fluid.

As shown in FIGS. 6 and 10 , an outer portion of second wall 714includes a thickened annular region 724. Region 724 includes walls 722which taper to the thinner regions of second wall 714. According to anembodiment, first wall 712 and second wall 714 are generally parallel tocentral axis A and perpendicular to wall 720, but are not limited tothis configuration. As shown in FIG. 6A, region 724 allows cap 700 to befixedly attached to and seal capture cylinder 710. For example, cap 700may be snap-fit, welded, glued, screwed, or attached in any manner knownin the art to capture cylinder 710. Attachment of cap 700 to capturecylinder 710 may allow cap 700 to be removed, for example, using screwthreads. Alternatively, cap 700 may be fixedly secured to cylinder 710and unable to be removed without destroying regulator 40, for example,by welding cap 700 to capture cylinder 710. Cap 700 may be configured soas to compress spring 740 by a predetermined amount in a relaxed stateof regulator 40, when pressurized fluid is not flowing into/throughregulator 40. The predetermined compression of spring 740 may determinea pressure that is output via output opening 654 when high pressurefluid flows through input opening 652. A compression of spring 740 bycap 700 may be adjustable after regulator 40 is assembled (e.g., toallow for varying output pressures) or could be fixed during assembly ofregulator 40.

With continued reference to FIG. 6A, membrane 730 is provided in firstchamber 716 of capture cylinder 710. Membrane 730 includes a base 732and a wall 734 extending along a circumference of and generallyperpendicular to base 732. According to an embodiment, membrane 730 isformed of a silicone material, but is not limited thereto. For example.membrane 730 may be any material which is flexible and reduces afriction coefficient between membrane 730 and the other structures ofregulator 40.

As shown in FIG. 6A, membrane 730 covers top wall 683 and the upperopening of second chamber 660 of body 650. An inner diameter of wall 734is approximately equal to an outer diameter of an upper portion ofregulator wall 656 of body 650, allowing membrane 730 to seal the upperopening of second chamber 660. As will be discussed herein, thisprevents fluid from escaping body 650 (other than through output opening654) during operation of regulator 40. When assembled, a lower surfaceof step portion 720 of capture cylinder 710 contacts a top surface ofbase 732 and fixes membrane 730 to base 650. In that way, membrane 730is squeezed between cylinder 710 and base 650. For example, as shown inFIG. 6A, capture cylinder 710 is screwed to body 650, but may besnap-fit, welded, glued, or attached in any manner known in the art.Alternatively, or additionally, membrane 730 may be fixed to base 650independent of capture cylinder 710, such as using an adhesive.According to an example, to reduce the sensitivity of a changingpressure at inlet 632, membrane effective diameter, which is the outerdiameter of second chamber 660 in contact with membrane 730, isapproximately 0.6 inches to 1.25 inches, and preferably 0.7 inches to1.0 inch.

An operation of regulator 40 will now be described.

FIG. 6A shows regulator 40 in a configuration in which third chamber 666is sealed, meaning that fluid may not pass through hole 664 and thatthird chamber 666 is not in fluid communication with second chamber 660and output opening 654. FIG. 6B shows regulator 40 in a configuration inwhich third chamber 666 is not sealed (fluid may pass through hole 664such that third chamber 666 is in fluid communication with secondchamber 660 and output opening 654), but regulator 40 is not receivinghigh pressure fluid from a source such as containment device 20, 20′.FIG. 6C shows regulator 40 in a configuration in which third chamber 666is not sealed (fluid may pass through hole 664 such that third chamber666 is in fluid communication with second chamber 660 and output opening654) and regulator 40 is receiving high pressure from a fluid sourcesuch as containment device 20, 20′.

With reference to FIG. 6B, when regulator 40 is not exposed to any highpressure (e.g., when a containment device 20, 20′, which is not shown inFIGS. 6A-6C, is not installed or when pierce pin 670 has not yetpunctured containment device 20, 20′), regulator 40 is in a restingstate of equilibrium, as shown in FIG. 6B. In the resting state, spring740 may exert a force in a first direction along central axis A, towardpierce pin 670. The force in the first direction from spring 740 may betransmitted to piston 690 and membrane 730, which may transmit a forcein the first direction to actuator 680 (including prong 688). When prong688 is in contact with ball bearing 750, prong 688 may transmit a forcein the first direction to ball bearing 750 and, in turn, to spring 742.

Meanwhile, spring 742 may exert a force in a second, opposite directionalong central axis A, toward upper cap wall 703 (a direction oppositethe force exerted by spring 740). A force from spring 742 may betransmitted to ball bearing 750, which may, via contact with prong 788,exert a force in the second direction on actuator 780, membrane 730,piston 690, and spring 740. Spring 742 may be configured to urge ballbearing 750 in the second direction, toward O-ring 760.

A spring constant of spring 740 may be larger than a spring constant ofspring 742 (i.e., spring 740 may be stiffer than spring 742). Due to thelarger spring constant of spring 740, spring 740 may dominate spring742. In the resting state of FIG. 6B, membrane 730 may be deformed suchthat it protrudes in the first direction, toward pierce pin 670. Prong688 may press in the first direction against ball bearing 750 such thatthere is a gap between ball bearing 150 and O-ring 160, and thirdchamber 666 is unsealed/open, so that fluid may pass through hole 664and third chamber 666 is in fluid communication with second chamber 660and output opening 654.

After high pressure is introduced to regulator 40, as shown in FIG. 6C,high-pressure fluid may pass through input opening 652, through piercepin chamber 676, and into third chamber 666. Fluid may then pass throughthe gap between ball bearing 750 and through hole 664 into actuatorchamber 684. Fluid may then flow between actuator 680 and protrusion 662to second chamber 660. As shown in FIG. 6C, fluid may also pass viathroughhole 686 to second chamber 660. Fluid subsequently passes as afluid through output opening 654 (shown by arrow E).

When actuating devices 634 are not actuated, valves (not shown) areclosed, and fluid does not flow through delivery system 10. Fluid may beprevented from passing downstream (toward outlet 34) of a portion ofdelivery system 10 (e.g., a valve) controlled by actuating devices 36 a,36 b. Therefore, pressure may build up in portions of system 10 that areupstream (away from outlet 34) of that portion (e.g., valve) of deliverysystem 10. Regulator 40 may be upstream of that portion (e.g., valve),and therefore pressure may build up in regulator 40.

The increasing pressure within regulator 40 may affect variouscomponents of regulator 40 and may cause regulator 40 to transition fromthe configuration of FIG. 6C (open/unsealed) to the configuration shownin FIG. 6A (closed/sealed). For example, pressurized fluid building insecond chamber 660 may result in a force on membrane 730 in the seconddirection. This force may be transmitted to piston 690 and spring 740.Pressurized fluid in third chamber 666 may also result in a force onball bearing 750 in the second direction. This force on ball bearing 750may be transmitted to actuator 680, membrane 730, piston 690, and spring740.

These additional forces in the first direction may overcome a force ofspring 740 in the first direction, such that ball bearing 750, actuator680, membrane 730, and piston 690 move in the second direction, towardupper cap wall 703. Membrane 730 may be flat or approximately flat inthe configuration shown in FIG. 6A, as shown. Membrane 730 may also becapable of deforming further in the second direction so that membrane730 protrudes in the second direction. For example, membrane 730 mayprotrude or bow in the second direction when sufficient force is exertedon ball bearing 750, such as in a fully pressurized configuration. Itwill be appreciated that FIGS. 6A-6C are merely exemplary and that arange of positions of the components of regulator 40 may be possible.For example, in a resting equilibrium (when regulator 40 is not exposedto pressurized fluid), membrane 730 may be straight and may protrude inthe second direction when regulator 40 is pressurized.

In the configuration of FIG. 7A, ball bearing 750 may press againstO-ring 760, forming a seal between ball bearing 750 and O-ring 760. Whenball bearing 750 and O-ring 760 are sealed, third chamber 666 may besealed such that fluid may not move through hole 664 into actuatorchamber 684. Arrows in FIG. 6A show a path of fluid flow when fluid isflowing into input opening 652 but cannot exit hole 664. Thus, apressure of fluid in second chamber 660 (and areas downstream of outputopening 654) may be capped at a certain value (e.g., the regulatedpressure of between 25 and 100 PSI, as discussed below). As discussed infurther detail below, this regulation of pressure in second chamber 660occurs both when actuating devices 634 are actuated or are not actuated.This pressure regulation protects components of delivery system 10, aswell as a subject of a procedure using delivery system 10. Eventually,where a discrete containment device 20, 20′ is used, pressure in thirdchamber 666 may equalize with a pressure of containment device 20, 20′,such that fluid no longer flows from containment device 20, 20′ throughinput opening 652.

When actuating devices 36 a, 36 b are opened, fluid may be free totravel from outlet 34 because downstream valves are open. Thus, fluidmay flow from second chamber 660 and out of output opening 654, therebyequalizing pressure between second chamber 660 and the atmospheresurrounding application device 30. Because second chamber 660 is nolonger at a high pressure, the fluid in second chamber 660 may no longerexert a force in the second direction on membrane 730. As a result, thenet force along the second direction may decrease (althoughhigh-pressure fluid continues to exert a force on ball bearing 750 inthe second direction), and regulator 40 may transition to aconfiguration like that shown in FIG. 6C. The force of spring 740pushing against piston 690 and membrane 730 in the first directioncauses actuator 680 to move toward pierce pin 670 along central axis A.Movement of actuator 680 toward pierce pin 670 causes prong 688 to pushball bearing 750 against spring 742, thereby providing an openingthrough hole 664 of protrusion 662. It will be appreciated that anamount that hole 664 is open may vary depending on a balance of theforces in the first direction (exerted by spring 740) and in the seconddirection (exerted by spring 742, and high-pressure fluid on membrane730 and ball bearing 750). FIG. 6C shows an exemplary openconfiguration. However, portions such as membrane 730, actuator 680,and/or ball bearing 750 may vary in their position depending on thebalance of forces acting at that time, allowing more or less fluid topass through hole 664. A varying amount of fluid passing through hole664 may facilitate maintaining second chamber 660 at a desired regulatedpressure (described in further detail below).

While the third chamber 666 is unsealed (FIG. 6C), pressurized fluid mayflow from containment device 20, 20′, through input opening 652, andthrough hole 664. For example, as shown in FIG. 6C, a flow path (arrowsin FIG. 6C) shows a fluid input I through input opening 652. Fluid flowsin the direction of the arrows through pierce pin chamber 676 and intothird chamber 666. Fluid flows through hole 664 into actuator chamber684, and flows between actuator 680 and protrusion 662 to second chamber660. As shown in FIG. 6C, fluid may also pass via throughhole 686 tosecond chamber 660. Fluid subsequently passes as a fluid through outputopening 654 (shown by arrow E). The fluid output is controlled byregulator 40, as described herein. While not shown, one or more devices,such as a tube, a catheter, or an application tip, may be attached tooutlet 34 to aid in supplying fluid to a desired location, as will bedescribed in detail herein.

If high pressure fluid accumulates in second chamber 660, the pressuremay exert a force in the second direction on membrane 730, as describedabove, causing membrane 730 to move in the second direction. This forcemay be transmitted to piston 690. Pressurized fluid in third chamber 666may also result in an a force on ball bearing 750 in the seconddirection, as discussed above. These forces, together or separately, maycause regulator 40 to transition to a configuration in which thirdchamber 666 is sealed via ball bearing 750 and O-ring 760 (as shown inFIG. 6A). The interactions described above may cause regulator 40 toiteratively transition between configurations in which third chamber 666is sealed or unsealed.

Using the mechanisms described herein, regulator 40 controls a fluidpressure supply through output opening 654. For example, the pressure iscontrolled by regulating the opposing forces of spring 740 on one sideand spring 742 and fluid pushing against ball bearing 750 and membrane730 on the other side.

The spring force of springs 740 and 742 are predetermined based on adesired pressure of a fluid that is to be dispersed and a desired rateat which the fluid is to be dispersed. For example, a spring with alower rate (i.e., lowest amount of weight to compress a spring one inch)and higher compression/compressibility may achieve greater control overa pressure of fluid through output opening 654. For example, accordingto an embodiment, regulator 40 may be designed to supply a hemostaticagent to a tissue at a pressure between approximately 25 and 100 PSI,and more particularly between approximately 40 to 60 PSI, and at a rateof approximately 5 to 15 liters per minute (LPM), and more particularlybetween 7 and 10 LPM. Regulator 40 provides a consistent pressure andflow of fluid from containment device 20, 20′.

As fluid is released from containment device 20, 20′, a pressurereleased from containment device 20, 20′ changes, for example, from ahigh pressure (approximately 850 PSI) to zero PSI when containmentdevice 20, 20′ is empty. As the pressure in containment device 20, 20′decreases, the pressure of fluid against ball bearing 750 and membrane730 changes (e.g., lessens), reducing the force exerted in the seconddirection against spring 740. Thus, as the pressure in containmentdevice 20, 20′ decreases, the force of spring 740 causes a greaterportion of hole 664 to be open, thereby providing a consistent rate offlow and pressure of the fluid supply at output 654. However, a pressureof fluid from containment device 20, 20′ may be great enough to continueto exert forces on ball bearing 750 to provide sealing of chamber 666via contact between ball bearing 750 and O-ring 760 when regulation ofpressure is required.

The configuration shown in FIG. 6A improves consistency of flow rate andoutput pressure of fluid. For example, membrane 730 is a silicone orother friction-reducing material. Silicone may remain flexible at lowtemperatures that may be present in regulator 40 due to high flow ratesof fluid from containment device 20, 20′. That is, as actuator 680 movesalong central axis A, there is no structure, such as an O-ring, insecond chamber 660 between and in contact with actuator 680 and an innersurface of regulator wall 656 of body 650. Such a structure would causefriction forces, making it difficult for actuator 680 to move, therebydecreasing the consistency at which a flow rate and output pressure of afluid may be maintained. Thus, regulator 40 of FIG. 6A minimizesfriction forces when actuator 680 and piston 690 are moved along centralaxis A, providing improved consistency in the flow rate and outputpressure of the fluid.

FIG. 7 illustrates another embodiment of a regulator 40′. Like elementsin FIG. 7 have like reference characters as those in FIG. 6A. As shownin FIG. 7 , regulator 40′ has some different structures for regulatingfluid flow and pressure. Further, regulator 40′ illustrates a snap-fitconnection between capture cylinder 710′ and body 650′. For example, inthe embodiment illustrated in FIG. 7 , a regulator wall 656′ is snap fittogether with a first wall 712′ of capture cylinder 710′. Additionally,and or alternatively, capture cylinder 710′ and body 650′ may beattached by adhesive, welding, or any other attachment mechanism knownin the art.

As shown in FIG. 7 , actuator 680′ interacts with a poppet 770. Poppet770 includes a body 772, tabs 774, and a protrusion 776. One end ofprotrusion 776 is configured to contact actuator 680′. Protrusion 776may be fixed to actuator 680′ by, example, adhesion or welding, to allowprotrusion 776 and actuator 680′ to move together, as discussed ingreater detail herein. Protrusion 776 extends through hole 664 in base650′, and O-ring 760′ seals the space between hole 664 and tabs 774.O-ring 760′ may be a resin or any other material known in the art (e.g.,silicone) for fluidly sealing an opening. According to an example, aseal effective diameter where O-ring 760′ seals against the spacebetween hole 674 and tabs 774 is approximately 0.05 inches to 0.14inches, and preferably approximately 0.08 inches to 0.11 inches. Asfurther shown in FIG. 7 , body 772 extends into chamber 676 of piercepin 670, such that poppet 770 moves axially with respect to pierce pin670. For example, an outer wall 770 a of poppet 770 has a diametersmaller than a diameter of inner wall 676 a of chamber 676. In this way,fluid may flow from input opening 652 to third chamber 666. In theembodiment of FIG. 7 , a spring 744 is provided in second chamber 660,annularly disposed around cylindrical protrusion 662, and causesactuator 680′ to move along central axis A, as will be described herein.

As in FIG. 6A, O-ring 760′ in FIG. 7 is disposed adjacent inner wall 662a within third chamber 666 and lies adjacent to hole 664. Tabs 774 areadjacent to O-ring 760′ on the side opposite hole 664. O-ring 760′ maybe fixed relative to tabs 774. For example, tabs 774 may include groovesor alternative structures for receiving O-ring 760′. As will bedescribed herein, tabs 774 and O-ring 760 are capable of sealing hole664 from communication with third chamber 666 when O-ring 760′ ispressed against inner wall 662 a. Third spring 744 is disposed in secondchamber 660 between, and in contact with both of, actuator 680′ and base650. Third spring 744 is sized to have an outer diameter smaller than anouter diameter of second chamber 660, such that third spring 744 canexpand and contract without creating friction forces between it and anouter wall of second chamber 660. O-ring 760′ and tabs 774 are sizedsuch that an outer diameter of each is less than the diameter of innerwall 662 a. In that way, when O-ring 760′ and/or tabs 774 are notsealing hole 664, fluid flows between inner wall 662 a and tabs 774and/or O-ring 760′ and through hole 664 to chamber 660.

An operation of regulator 40′ will now be described. Regulator 40′ ofFIG. 7 operates in a similar manner as described with reference to FIG.6A. Regulator 40′ may have a first, sealed, configuration, shown in FIG.7 , in which O-ring 760′ presses against inner wall 662 a and creates aseal such that fluid may not pass between O-ring 760 and inner wall 662a or between O-ring 760′ and tabs 774. Thus, fluid may be unable to passthrough hole 664, Regulator 40′ may have a second, unsealedconfiguration (not shown), in which O-ring 760′ does not form a sealwith inner wall 662 a and/or tabs 774, so that fluid may flow throughhole 664.

Spring 744 provides an opposing force to spring 740. When one or moreactuating devices 36 a, 36 b of application device 30 are manipulated, apressure between second chamber 660 and an atmosphere surroundingapplication device 630 are equalized, thereby transitioning regulator40′ from the sealed configuration of FIG. 7 (where O-ring 760′ preventspassage of fluid through hole 664) to an unsealed configuration (whereO-ring 760′ does not prevent passage of fluid through hole 664) and thusreleasing fluid. As discussed herein, during the release of fluid,spring 740 presses piston 690 against membrane 730, thereby pressingactuator 680′ toward pierce pin 670. Movement of actuator 680′ towardpierce pin 670 causes poppet 770, including O-ring 760′, to move in thefirst direction, toward pierce pin 670. As poppet 770 moves in the firstdirection, a space is created between O-ring 760′ and inner wall 662 a.Fluid from containment device 20, 20′ may flow through the space betweenO-ring 760 and inner wall 662 a and pass through hole 664.Alternatively, tabs 774 of poppet 770 to loosen around O-ring 760,thereby creating an opening between third chamber 666 and hole 664.Fluid may move from containment device 20, 20′, through chamber 676 ofpierce pin 670, into second chamber 660, and through output opening 654,as shown by the flow path in FIG. 7 . Although regulator 40′ is shown ina configuration in which fluid may not pass through output opening 654,due to a seal between tabs 774 and O-ring 760′, the flow path in FIG. 7shows how fluid would flow when tabs 774 are loosened around O-ring760′. The configuration shown in FIG. 7 similarly improves consistencyof flow rate and output pressure of fluid. The configuration of FIG. 7 ,in particular, may reduce a sealing diameter between O-ring 760′, tabs774, and inner wall 662 a. This decreased diameter may allow forincreased sealing, which may prevent fluid from passing through hole 664when such passage would cause a deviation from the desired regulatedpressure. As discussed with regard to FIGS. 6A-6C, movement of membrane730 and actuator 680′ may allow for dynamic adjustment of an amount offluid that may pass through hole 664 and exit output opening 654.

As discussed herein, membrane 730 reduces a friction between actuator680 and body 650. This reduced friction provides more freedom ofmovement between elements, thereby improving the consistency of theoutput pressure and flow rate of the fluid. As also described herein,throughhole 686 may be provided in actuator 680. Throughhole 686 mayassist in providing a consistent pressure and consistent rate of fluidflow from output 654.

FIGS. 11A and 11B show a further exemplary regulator 40″, which may haveany of the properties of regulators 40 or 40′, described above, andwhich may be used in conjunction with delivery system 10. Although allof the features of regulator 40″ corresponding to those of regulator 40may not be discussed in the description below, it will be appreciatedthat those features may be present in regulator 40″, unless explicitlystated otherwise. Like reference numbers denote correspondingstructures. FIG. 11A shows regulator 40″ with third chamber 666 sealed,and FIG. 11B shows regulator 40″ with third chamber 666 unsealed.

Regulator 40″ may include an X-ring seal 760″ (e.g., a quad-ring seal).X-ring seal 760″ may have an approximately X-shaped cross-section withrounded corners. X-ring seal 760″ may have a central circumference andfour protrusions 762, 764, 766, 768 extending radially outward from thecentral circumference. Alternatively, X-ring seal 760″ may have othersuitable numbers of protrusions. X-ring seal 760 may have across-section similar to an asterisk where X-ring seal 760″ has morethan four protrusions.

X-ring seal 760″ may be fitted against inner wall 662 a of cylindricalprotrusion 662. For example, inner wall 662 a may have a groove orgrooves in which X-ring seal 760″ may be received. Protrusions 764, 766,and 768 may each be in contact with one or more surfaces of inner wall662 a. For example, as discussed below, surfaces 662 aa, 662 ab of innerwall 662 a may form a corner in which X-ring seal 760″ may be received.Each of surfaces 662 aa and 662 ab may face third chamber 666.

As compared with an O-ring, X-ring seal 760″ provides additional pointsof contact with inner wall 662 a. When points of contact are referred toherein, it will be appreciated that contact between X-ring seal 760″ andinner wall 662 a may extend over more than just a single point and mayinclude a larger (and possibly continuous) area of contact.

X-ring seal 760″ may provide four points of contact with inner wall 662a. First surface 662 aa of inner wall 662 a may be perpendicular orapproximately perpendicular to axis A. Second surface 662 ab of innerwall 662 a may be parallel or approximately parallel to axis A. Firstsurface 662 aa and second surface 662 ab may meet at a corner.Protrusion 768 may contact first surface 662 aa at point W (shown in theinset of FIG. 11A). Protrusion 764 may contact second surface 662 ab atpoint X. Protrusion 766 may have points of contact with both secondsurface 662 ab (at point Y) and first surface 662 aa (at point Z). Incontrast, an O-ring would provide only one point of contact with firstsurface 662 aa and one point of contact with second surface 662 ab.Therefore, X-ring seal 760″ provides more redundant sealing than anO-ring by providing additional, separate points of contact. Points W, X,Y, and Z may be separated from one another by a gap or space. Even wereone or more points of contact to be breached, other points of contactmay provide sealing. X-ring seal 760″ could maintain sealing even withtwo (or three) points of contact broken, while an O-ring with two pointsof contact broken would fail to provide a seal. Furthermore, havingseparated points of contact W, X, Y, Z may provide for suction effects,increasing sealing.

A surface area of each of contacts W, X, Y, Z between X-ring seal 760″and inner wall 662 a may be smaller than a surface area of each contactbetween an O-ring and inner wall 662 a would be. As compared to O-ring760, the protrusions 762, 764, 766, 768 of X-ring seal 760″ may providenarrower, more focused points of contact between X-ring seal 760″ andinner wall 662 a. A radius of curvature of each of protrusions 762, 764,766, and 768 may be less than a radius of curvature of an O-ring,producing more defined points of contact.

When ball bearing 750″ (or another type of body) presses against andcontacts X-ring seal 760″ (at at least one point), these more focusedcontacts may provide for increased sealing, as compared to an O-ring.Because, as compared to an O-ring, the same (or similar) force isexerted by ball bearing 750″ over a smaller area, a greater pressure maybe exerted on protrusions 762, 764, 766, 768 of X-ring seal 760″, whichmay provide for increased sealing. Due to the shape of protrusions 762,764, 766, 768, pressure exerted at each point of contact between X-ringseal 760″ and ball bearing 750″ or inner wall 662 a may be greater thancorresponding pressures of an O-ring. As discussed in further detailbelow, even when ball bearing 750″ exerts a relatively smaller force(e.g., when pressure has dropped in containment device 20, 20′), X-ringseal 760″ may provide a more reliable seal against ball bearing 750″, ascompared to an O-ring.

X-ring seal 760″ may have a durometer measurement that is chosen toresult in the desired sealing properties, described below. For example,the durometer measurement may be 70 or approximately 70. Durometermeasurements of seal 760″ may range from approximately 55 toapproximately 90, and, more particularly, from approximately 70 toapproximately 80. X-ring seal 760″ may be formed of a material thatenables X-ring seal 760″ to retain elastomeric properties in conditionssuch as those which may be present in regulator 40″ during operation ofdelivery system 10 (e.g., in cold temperatures such as those ofapproximately −50 degrees C. (e.g., between approximately −40 degrees C.and approximately −60 degrees C.)). For example, X-ring seal 760″ may beentirely formed from or may include silicone, rubbers (such as nitrilerubbers), and/or polyurethane. An X-ring seal having the qualities ofX-ring seal 760″ may be used as an alternative to O-ring 760 or 760′ inregulators 40, 40′, above. O-ring 760 or 760′ may have durometer and/ormaterial features of X-ring seal 760″, described above.

Regulator 40″ may also include ball bearing 750″. A material formingball bearing 750″ (or portions thereof) may have a durometer measurementchosen to achieve the desired sealing between ball bearing 750″ andX-ring seal 760″, described below. For example, a durometer measurementof ball bearing 750″ may be 90 or approximately 90. A durometermeasurement of ball bearing 750″ may range from approximately 80 toapproximately 90. A composition of ball bearing 750″ may be such thatball bearing 750″ does not freeze to other components of regulator 40″when exposed to solid, liquid, and/or freezing gaseous carbon dioxide.For example, ball bearing 750″ may be formed entirely of or may includerubber, silicone, nitrile, polyurethane, steels, and/or ceramics. A ballbearing having the characteristics of ball bearing 750″ may be used asan alternative to ball bearing 750 in regulator 40, above, either inconjunction or separately from X-ring seal 760″ (i.e., regulator 40 mayuse structures having qualities of either or both of X-ring seal 760″and ball bearing 750″).

X-ring seal 760″ may have a 1/16-inch cross section (measured along aline B, shown in the insert of FIG. 11A), a 5/64- 7/64-inch internaldiameter (measured along a line C, shown in FIG. 11A), and a 13/64-15/64-inch outer diameter (measured along a line D, shown in FIG. 11A).X-ring seal 760″ may have a cross section between approximately 1/32inch and approximately 3/32 inch, an internal diameter betweenapproximately 1/16 inch and approximately ⅛ inch, and an outer diameterbetween approximately 6/32 inch and approximately ⅛ inch. Ball bearing750″ may have a diameter of approximately 0.188 inches. Similar oralternative sizes may be used, either in regulators 40″ for use withsystem 10 or regulators 40″ for use in alternative systems. A size ofball bearing 750″ may not exceed a diameter of third chamber 666 and maybe greater than an internal diameter of X-ring seal 760′. For example,ball bearing 750″ may have a diameter between 0.125 inches and 0.25inches. For example, a regulator 40″ used with an alternative system mayhave different dimensions than a regulator 40″ used with system 10.

An operation of regulator 40″ will now be described. Regulator 40″ ofFIGS. 11A-11B operates in a similar manner as described with referenceto FIGS. 6A-6C. Operation of regulator 40″ will therefore not beseparately described in detail. Differences between an operation ofregulator 40 and regulator 40″ are described below.

Like ball bearing 750 and O-ring 760, ball bearing 750″ and X-ring seal760″ may be capable of sealing hole 664 from communication with thirdchamber 666. FIG. 11A shows regulator 40″ with third chamber 666 sealedso that fluid cannot pass through hole 664. In certain configurations ofregulator 40″, (as shown in FIG. 11A), ball bearing 750″ may exert aforce against protrusion 762 of X-ring seal 760″. Such configurationsare described above, with respect to regulator 40.

As discussed above, a seal between ball bearing 750″ and X-ring seal760″ may be stronger than a seal between a ball bearing (such as ballbearing 750) and an O-ring seal (such as O-ring 760). As discussedabove, protrusion 762 has a smaller radius of curvature than O-ring 760.Therefore, for a given force, ball bearing 750″ exerts a larger pressureon protrusion 762, which provides for tighter sealing between X-ringseal 760″ and ball bearing 750″.

As ball bearing 750″ presses against protrusion 762, second, third, andfourth protrusions 764, 766, 768, respectively, may press againstsurfaces 662 aa and 662 ab at points W, X, Y, and Z. As discussed above,protrusions 664, 666, and 668 may provide redundant sealing due to theincreased number of contact portions.

The increased sealing provided by ball bearing 650″ and X-ring seal 660″may increase performance of regulator 40″. For example, increasedsealing may prevent fluid from leaking through hole 664 when a pressureshould be regulated and third chamber 666 should be sealed. Furthermore,as described above with respect to regulator 40, pressure of fluidreleased from containment device 20, 20′ may change over time. Inparticular, pressure from containment device 20, 20′ may decrease overtime. As pressure from containment device 20, 20′ decreases, a forceexerted by the pressurized fluid, in the second direction, on ballbearing 750″ may decrease. However, to achieve the desired, regulatedpressure, sealing of chamber 666 may be required. When an O-ring isused, the decreasing force exerted by ball bearing 750″ may result ininsufficient pressure to seal chamber 666. Because of the smallerarea/volume of protrusion 762, a smaller force may be required in orderto exert a sealing pressure on X-ring seal 760″. Therefore, as pressurefrom containment device 20, 20′ decreases, X-ring seal 760″ may maintainsealing of chamber 666 when desired, while an O-ring may lessconsistently maintain sealing under similar circumstances. The increasedsealing accomplished by X-ring seal 760″ may result in increasedperformance of regulator 40″.

Although many of the features of regulator 40, 40′, 40″ are described ascylindrical, the shape of the elements are not limited thereto. Rather,the features may be any shape suitable for regulator 40, 40′, 40″ toproperly regulate a fluid dispersion from containment device 20, 20′.Moreover, unless described otherwise, the structural elements ofapplication device 30 and/or regulator 40, 40′, 40″ may be any materialknown in the art, including but not limited to a metal alloy, a ceramic,and/or a resin.

With reference to FIG. 12 , a relief valve 62 according to an embodimentis shown. Relief valve 62 is positioned along second fluid path 48between membrane regulator 44 and container 100 (housing 107 ofcontainer 100 is not shown in FIG. 12 for ease of understanding) to ventpropellant fluid from containment device 20, 20′ if, e.g., one or moreof membrane regulator 44 or regulator 40 fails. For example, reliefvalve 62 includes a burst disc 62 a that may rupture when a pressure atrelief valve 62 is greater than a final, predetermined regulatedpressure, e.g., a pressure of the propellant fluid after passing throughproperly functioning and properly adjusted regulator 40 and membraneregulator 44. A pressure at which burst disc 62 a will burst may beapproximately 20 PSI to 150 PSI, more preferably approximately 50 PSI to70 PSI, and more preferably approximately 60 PSI. It will be understoodthat the burst pressure of burst disc 62 a may be modified, or a burstdisc 62 a having a different burst pressure may be used, based on thedesired output pressure from membrane regulator 44. It will also beunderstood that relief valve 62 is not limited to burst disc 62 a, andmay be any relief valve suitable for venting propellant fluid at apressure greater than a desired output pressure such as, e.g., a pilotvalve or the like. It will further be understood that relief valve 62 isnot limited to being positioned as shown in FIG. 12 , and may bepositioned at any location between containment device 20, 20′ and outlet34 to prevent propellant fluid and/or a mixture of propellant fluid andmaterial from being released from application device 30 above a desiredpressure. Additionally, or alternatively, relief valve 62 may be placedat any position along a fluid path to release fluid pressure.

Container 100 according to an embodiment is shown in FIG. 13 . Asdiscussed above, container 100 may contain a powder, a fluid, or othersubstance to be mixed with the propellant fluid from containment device20, 20′ and dispensed through outlet 34 to catheter 190. Container 100includes an inner chamber 106 defined by housing 107 of container 100and a surface 109 of application device 30, which defines a bottommostsurface of inner chamber 106. Inner chamber 106 contains the powder,fluid, or other substance. According to an example, housing 107 is aclear material to visualize inner chamber 106, but the invention is notlimited thereto. Propellant fluid enters container 100 from second fluidpath 48 via a chamber inlet 102 (see FIGS. 14A and 14B). Propellantfluid passes through filters 104 provided in filter holes 104 a inbottommost surface 109 of inner chamber 106, which contains the powderor fluid, of container 100 (as described above, propellant fluid enterscontainer 100 via the plurality of sixth pathway O via the filter holes104 a). While two filter holes 104 a are shown in FIG. 13 , container100 may include any number of filter holes 104 a, such as one to fourfilter holes 104 a. Filters 104 may be sized to have holes approximately25 to 50 microns in diameter to prevent powder or fluid from innerchamber 106 from passing from inner chamber 106 back through secondfluid path 48, which may clog and/or contaminate application device 30.

With continued reference to FIG. 13 , inner chamber 106 includes achamber relief valve 108. Chamber relief valve 108 may be similar torelief valve 62 and may be, e.g., a burst disc or any other pressurerelief valve known in the art. As with relief valve 62, chamber reliefvalve 108 relieves pressure when a pressure within application device30, and specifically chamber 106, is greater than the final regulatedpressure e.g., relief valve 108 burst pressure may be approximately 20PSI to 150 PSI, more preferably approximately 50 PSI to 70 PSI, and morepreferably approximately 60 PSI. While chamber relief valve 108 isprovided in the bottommost surface of inner chamber 106, the location ofrelief valve 108 is not limited thereto. While not shown, relief valve108 may vent propellant gas through a lumen provided in bottommostsurface 109 of inner chamber 106.

A tube 110, such as a hypotube, extends from and generally perpendicularto bottommost surface 109 of inner chamber 106 toward a topmost surfaceof inner chamber 106, but it not limited to this configuration. As shownin FIGS. 12 and 13 , a slot 112 is provided in, and through a wall of,tube 110 near the bottommost surface of inner chamber 106. Slot 112 isfluidly connected to a chamber outlet 114 (see FIGS. 14A and 14B), whichconnects to outlet 34, and allows a mixture of propellant fluid and thefluid or powder from inner chamber 106 to be dispensed from innerchamber 106 to outlet 34. Alternatively, or additionally, there mayexist a plurality of slots 112 circumferentially arranged about alongitudinal axis A of tube 110, which may provide additional dispensingoutlets from inner chamber 106. According to another example, slot 112may be one or more circular (or other-shaped) holes provided in tube110. The shape, number, and arrangement of slot 112 may aid indispensing an appropriate amount of the propellant fluid and powdermixture from inner chamber 106 to chamber outlet 114, and the number ofslots 112 may change according to a desired output. According to anexample, the area of slot(s) 112 (either the area of a single slot 112or the sum of the area of all slots 112) may be approximately 0.0025square inches to 0.030 square inches, and more preferably 0.0046 squareinches to 0.025 square inches, depending on the desired delivery rate ofthe propellant fluid and material mixture. Further, slot(s) 112 may beapproximately 0.05 to 0.2 inches from filter holes 104 a.

Container 100 may contain one or more spacers 216 (see FIG. 12 )extending from the bottommost surface of inner chamber 106. Spacers 216may alter the movement of material and/or propellant fluid throughcontainer 100, as will be described in greater detail below. It will beunderstood that container 100 may be formed without spacers 216.

As shown in FIGS. 13, 14A, and 14B, a ring or wheel-shaped attachmentmember 116 includes spokes 116 a, is attached to and extends from asheath 118 (described in detail below) and is attached to an innersurface of housing 107. Attachment member 116 connects sheath 118 tohousing 107, such that a movement of housing 107 causes concurrentmovement of sheath 118. Attachment member 116 (and spacers 216 in thoseembodiments that include spacers 216) may fill one or more voids withininner chamber 106 to alter the movement of materials therein. Forexample, attachment member 116 and spacers 216 may fill voids that wouldprevent material from properly mixing with the material located withininner chamber 106 and/or prevent the mixture from being appropriatelydispensed through slot 112. Attachment member 116 and spacers 216 mayfurther create new and/or additional pathways for the combination ofpropellant fluid and materials to take through inner chamber 106. Forexample, as shown in FIGS. 14A and 14B, spaces exist between the spokes116 a of attachment member 116, allowing propellant fluid and materialto flow therebetween, while also changing the flow pattern of fluids andmaterials within container 100. These additional pathways may improvemixing of the propellant fluid with the materials and may ensure a moreconsistent amount of material is output from inner chamber 106.

With continued reference to FIG. 13 , sheath 118 is provided on an outersurface of and coaxial with tube 110. Further, a conical member 120 isadjacent the topmost surface of inner chamber 106, and may be integrallyformed with or otherwise fixed to housing 107. In a closedconfiguration, e.g., when inner chamber 106 is fluidly uncoupled fromapplication device 30 as shown in FIG. 14A, sheath 118 covers and sealsslot 112 and conical member 120 extends into and seals a distalmost end110 a of tube 110. This closed configuration prevents the materialprovided in inner chamber 106 from being contaminated and prevents thematerial from being dispensed before the physician is prepared todispense the material. In contrast, when inner chamber 106 is in an openconfiguration and inner chamber 106 is fluidly coupled with applicationdevice 30, as shown in FIG. 14B, slot 112 is exposed and distalmost end110 a of tube 110 is open to inner chamber 106. The open configurationallows a mixture of propellant fluid and material in inner chamber 106to be dispensed through slot 112 to outlet 34.

As further shown in FIG. 14A, one or more cams 122 are attached to aninner surface or an outer surface of housing 107 and are disposed in andmovable along a cam shaft 124. Cam shaft 124 is ramp shaped and slopeddownward from inner chamber 106 toward chamber inlet 102. In the closedconfiguration, achieved by twisting container 100 in the direction ofarrow Y in FIG. 14A, cam 122 is disposed at a first end 124 b of camshaft 124, which is positioned near inner chamber 106. In the openconfiguration, achieved by twisting container 100 in the direction ofarrow X in FIG. 14B, cam 122 is disposed at a second end 124 a of camshaft 124, which is opposite first end 124 b, as shown in FIG. 14B. Whencontainer 100 is twisted in the direction of arrow X, housing 107 movesupward, as shown in FIG. 14B. Since attachment member 116 is attached tothe inner side of housing 107, and since attachment member 116 is alsoattached to sheath 118, twisting container 100 in the direction of arrowX causes sheath 118 to also move upward and expose slot 112. Further,since conical member 120 is also attached to the inner side of housing107, moving container 100 upward exposes distalmost end 110 a of tube110.

To attach housing 107 to application device 30, cam 122 is placed intothe U-shaped groove 124 c of cam shaft 124. Housing 107 may then betwisted as described above in the direction of arrow Y to closecontainer 100, or in the direction of arrow X (from the closed position)to open container 100. According to an example, one or more O-ringsand/or sealing members may be provided between housing 107 andapplication device 30 to assist in fluidly sealing housing 107 toapplication device 30.

A method of operating medical device 10 will now be explained.Application device 30 and/or containment device 20′ may be packaged withcontainer 100 attached thereto or, alternatively, may allow forcontainer 100 to be attached to application device separately. Aftercontainer 100 is attached to application device 30, containment device20′ may be attached to inlet 42. For example, containment device 20′ maybe attached to application device 30 using locking mechanism 50.According to an example, containment device 20′ may be placed on asurface of piston 58 when lever 52 is in a first position, as shown inFIG. 4 . Lever 52 is subsequently pushed toward handle 31 about pivotaxis R, urging containment device 20′ towards inlet 42 via attachmentdevice 38. A pierce pin (not shown) on application device 30 breaks aseal (not shown) on containment device 20′, causing containment device20′ and application device 30 to be in fluid communication. Lever 52 isheld in a locked position when cam 57 rests in locking notch 56, whichmaintains a position of lever 52 adjacent handle 31 and maintainscontainment device 20′ toward inlet 42.

With reference to FIG. 2 , actuation of first actuator 36 a and secondactuator 36 b may independently control release of propellant fluidthrough application device 30. For example, actuation of second actuator36 b causes propellant fluid to travel along first fluid path 46, i.e.,through first pathway J, second pathway K, and fourth pathway L tooutlet 34, as shown in FIG. 3 . Use of this first fluid path 46 allows auser to purge material from outlet 34 and/or catheter 190, if catheter190 is attached to application device 30 (see FIG. 2 ). The pressure ofpropellant fluid released in application device 30 may be controlled asdescribed herein with reference to regulator 40.

With reference to FIGS. 14A and 14B, a user moves container 100 from afirst position (FIG. 14A) to a second position (FIG. 14B) by turningcontainer 100 in the direction X. As shown in FIG. 14B, slot 112 isexposed to inner chamber 106. Further, in the second position, theintermediate portion, including sixth pathways O and seventh pathway O′,is fluidly coupled with the distal portion, including eighth pathway P,and the proximal portion, including first, third, and fifth pathways J,M, and N, of the second fluid path 48. Subsequently, a user actuatessecond actuation device 36 a, causing propellant fluid to travel throughthe proximal portion of second fluid path 48 and into inner chamber 106.The propellant fluid mixes with a material, such as powder, in container100, and the material and propellant mixture is expelled through slot112 into the distal portion of second fluid path 48. The propellantfluid and material mixture exits application device at outlet 34,traveling down catheter 190 to distal end 193 (see FIG. 35 ). The useris able to direct the mixture to a target location by moving distal end193 to different locations.

Referring to FIGS. 15 and 16 , device 100′ for fluidizing and deliveringa powdered agent (e.g., a powdered therapeutic agent) to a site within aliving body (e.g., a target site) according to another embodiment. Thedevice (e.g., container) 100′ according to an example further comprisesan overtube (e.g., a sheath) 118′ movably mounted over a portion of thetube 110 so that the overtube 118′ may be moved along a length of thetube 110 to extend over the slot 112, controlling a size of an openingof the slot 112. Testing has shown that increasing the slot sizeincreases the powder delivery rate while decreasing the slot sizedecreases the powder delivery rate. The overtube 118′ is movablerelative to the tube 110 from an initial configuration, in which theovertube 118′ at least partially covers the slot 112 toward an openconfiguration, in which the overtube 118′ is moved along a length of thetube 110 to gradually increase the size of the slot 112 during thecourse of the treatment procedure so that the rate of delivery of thefluidized powder delivery may be maintained above a threshold level(e.g., be held substantially consistent over time) even as a volume ofthe powdered agent within the canister 107′ decreases as the powder isdispensed. It will be understood that a fluidized powder/materialincludes, but is not limited to, a powder/material that acquires thecharacteristics of a fluid by passing a propellant fluid (such as a gas)with in or through it, and also an agitized powder/material which is amaterial that follows a propellant fluid or is pushed by a propellantfluid.

According to an embodiment, a target delivery rate may be, for example,greater than 1 gram for every 5 seconds of delivery. The device 100′ mayprovide the best delivery results when the canister 107′ isapproximately 45% to 80% filled with the powdered agent. For example, at80% fill the target rate may be sustained for 30 delivery seconds. Thisdelivery rate is also dictated by the amount of gas that the device 100′may use for delivery. By gradually increasing the size of the slot 112through which the fluidized powder mixture may exit the canister 107′,the delivery rate may be maintained (e.g., past 30 delivery seconds)even as the volume of the powdered agent within the canister 107′decreases.

The canister 107′ in this embodiment extends longitudinally from an openfirst end 119 to a closed second end 121 to define the inner chamber106′, which is configured to receive the powdered agent therein. A lid(e.g., a surface) 109′ is coupled to the first end 119 to enclose theinner chamber 106′ and prevent the powdered agent and/or gas fromleaking from the inner chamber 106′. In one embodiment, the lid 109′ isreceived within the first end 119 and coupled thereto. The inlet (e.g.,filter hole) 104′ and/or an outlet (via slot 112) in this embodiment areconfigured as openings extending through the lid 109′. It will beunderstood by those of skill in the art, however, that the inlet 104′and the outlet may have any of a variety of configurations so long asthe inlet 104′ and the outlet are connectable to a gas source and adelivery member, respectively, for supplying a high flow gas to thepowdered agent to fluidize the powdered agent and deliver the fluidizedpowder mixture to the target site. For example, the inlet 104′ may becoupled to a connecting member (e.g. second fluid path) 48′ whichconnects the gas source to the inlet 104′. In an embodiment, gas may besupplied to the canister 107′ at a pressure ranging from between 5 and20 psi and/or a flow rate of 8-15 standard liters per minute. The outletin this embodiment is coupled to catheter 190′ sized, shaped andconfigured to be inserted through a working channel of a flexibleendoscope to the target site within a living body. In one example,catheter 190′ may have an inner diameter between 0.065 inches and 0.11inches. In another embodiment, the inlet 104′ and the outlet may extendthrough a portion of the canister 107′.

The tube 110 extends from a first end 128 connected to the outlet to asecond end (e.g., distalmost end) 110 a′ extending into the interiorspace 106′. As described above, the tube 110 in FIGS. 15 and 16 alsoincludes a slot 112, which extends through the wall of the tube 110. Theslot 112 in this embodiment is positioned proximate the first end 128 sothat the fluidized powder mixture may exit the interior space 106′ ofthe canister 107′ via one of second end 110 a′ of the tube 110 and theslot 112 proximate the first end 128.

The overtube 118′ is movably mounted over a portion of a length of thetube 110. The overtube 118′ is movable relative to the tube 110 so that,as the overtube 118′ moves over the tube 110, an area of the slot 112covered by the overtube 118′ is varied to control a size of a portion ofthe slot 112 exposed to the interior space 106′ and through which thefluidized powder mixture may exit the interior space 106′ of thecanister 107′. For example, in an initial configuration, the overtube118′ extends over the entire slot 112 so that the slot 112 is completelycovered, preventing any fluidized powder mixture from exitingtherethrough. During the course of treatment of the target site,however, the overtube 118′ may be moved relative to the tube 110 toincrease the size of the portion of the slot 112 exposed and throughwhich the fluidized powder may exit to maintain the delivery rate of thefluidized powder mixture at a desired level (e.g., above a thresholddelivery rate). For example, FIG. 16 shows the slot 112 partiallycovered via a portion of the overtube 118′ and FIG. 15 shows the slot112 entirely exposed. Although the embodiment describes an initialconfiguration in which the entire slot 112 is covered, it will beunderstood by those of skill in the art that, in an initialconfiguration, the overtube 118′ may have any of a variety of positionsrelative to the slot 112, so long as the size of the slot 112, throughwhich the fluidized powder may exit, is increased during the course oftreatment as the powder in the canister 107′ is dispensed.

It will also be understood by those of skill in the art that theovertube 118′ may be moved relative to the tube 110 via any of a varietyof mechanisms. In one embodiment, the overtube 118′ may be connected toa stabilizing ring 116′ which extends, for example, radially outwardfrom the overtube to an interior surface of the canister 107′ to fix aposition of the overtube 118′ relative to the canister 107′. Thecanister 107′ and the tube 110 in this example are rotatably coupled toone another so that, when the canister 107′ is rotated relative to thetube 110, the overtube 118′ correspondingly rotates about the tube 110while also moving longitudinally relative to the tube 110 to increase(or decrease, depending on the direction of rotation) a size of the slot112 through which the fluidized powder mixture may exit. In one example,the lid 109′, from which the tube 110 extends, includes cam paths 124extending along a partially helical path, within which an engagingfeature (e.g., protrusion 122 in FIGS. 14A and 14B) of the canister 107′rides so that, as the canister 102 and, consequently, the overtube 118′are rotated relative to the lid 109′ and the tube 110, the overtube 118′moves longitudinally relative to the tube 110. As would be understood bythose skilled in the art, the cam paths 124 and the correspondingengaging features of the canister 107′ function similarly to a threadedengagement between the canister 107′ and the lid 109′ to achieve thedesired relative movement between the overtube 118′ and the tube 110.

Although the embodiment describes the size of the portion of the slot112 available for fluidized powder mixture to exit as controlled via theovertube 118′, the size of the slot 112 may be controlled via any “door”having any of a variety of structures and geometries so long as the“door” may be gradually opened during the course of a treatmentprocedure to maintain a desired flow rate of therapeutic agent out ofthe canister 107′. Movement of the overtube 118′ or any other “door” maybe actuated mechanically, e.g., by physically twisting the overtube118′, or may be actuated pneumatically by the flow of gas. In addition,although the embodiment shows and describes a single slot 112, the tube110 may include more than one slot 112, which may be covered and/orexposed, as desired, via any of a number of door mechanisms, asdescribed above.

According to an example method using the device 100′, the canister 107′is filled with a powdered agent such as, for example, a hemostaticagent, prior to assembly of the device 100′. Upon filling the canister107′ with a desired amount of powdered therapeutic agent, the canister107′ is assembled with the lid 109′ to seal the powdered agent therein.The inlet 104′ is then coupled to the gas source via, for example, theconnecting member 48′ and the outlet is coupled to the catheter 190′.The catheter 190′ is then inserted to the target site within the livingbody (e.g., through a working channel of a delivery device such as, forexample, an endoscope). High flow gas is introduced into the interiorspace 106′ of the canister 107′ to form the fluidized powder mixture.The user may depress a trigger or other controller to spray thefluidized mixture and to deliver the fluidized mixture to the target are(e.g., a bleeding site) to provide treatment thereto. As the fluidizedpowder mixture is being delivered to the target site, the user mayphysically rotate the canister 107′ relative to the tube 110 to increasethe size of the slot 112 through which the fluidized mixture is exitingthe interior space 106′ to maintain a desired flow level. Alternatively,if a trigger is being used to control delivery of the fluidized powdermixture, when the trigger is depressed, a pneumatic cylinder or motormay be operated to rotate and move the lid 109′ relative to the canister107′ so that a larger cross-sectional area of the slot 112 is exposed,increasing the size of the slot 112 through which the fluidized mixturemay exit the interior space. Thus, as a volume of the powdered agentwithin the canister 107′ is decreased, the cross-sectional area of theslot 112 that is exposed is increased to maintain a substantiallyconstant delivery rate of the fluidized powder mixture. Alternatively,sensors may detect a flow rate and automatically control the opening ofthe slot 112 to ensure that a desired flow rate is maintained.

A device 200 according to another embodiment of the present disclosure,shown in FIG. 17 , is substantially similar to the device 100′ asdescribed above unless otherwise indicated. The device 200 comprises acanister 202 defining an interior space 204 within which a powderedagent is received. Similarly to the device 100, 100′, the interior space204 is enclosed via a lid 222 coupled thereto so that the powdered agentcontained within the interior space 204 forms a fluidized powder mixturewhen the interior space 204 is supplied with a high flow gas via aninlet 206. The fluidized powder mixture exits the interior space 204 viaan outlet 208 to be delivered to a target site within a patient duringtreatment. To maintain a desired delivery rate as the volume of thepowdered agent in the interior space 204 decreases during the course oftreatment, the lid 222 includes a turbulator plate 230. As gas passesthrough the turbulator plate 230, the turbulator plate 230 vibratesand/or rattles to prevent, or at least reduce, settling of the powderedagent contained within the canister 202. Without the turbulator plate230, during the course of treatment, some powdered agent would otherwisesettle into an equilibrium state, resisting fluidization and making itdifficult to maintain a desired delivery rate of the therapeutic agent.

Similarly to the canister 107′, the canister 202 extends longitudinallyfrom an open first end 218 to a closed second end 220 to define theinterior space 204. The lid 222 is coupled to the first end 218 toenclose the interior space 204 and contain the powdered agent therein.The inlet 206 and the outlet 208 are configured as openings extendingthrough the lid 222 in communication with the interior space 204.Although not shown, similarly to the device 100′, the outlet 208includes a tube extending therefrom and into the interior space 204 toallow the fluidized powder mixture to exit via the tube and the outlet208.

The turbulator plate 230 in this embodiment extends along a portion ofthe lid 222 which faces away from the interior space 204. In thisembodiment, the turbulator plate 230 includes an opening 232 extendingthrough a wall 234 thereof, the opening 232 being configured to beconnected to a gas source via, for example, a connecting element 224.The turbulator plate 230 extends along the lid 222 so that the opening232 is in communication with the inlet 206. Thus, gas passes through theturbulator plate 230 and into the interior space 204 via the inlet 206.An interior 236 of the turbulator plate 230 includes a plurality ofstructures 238 such as, for example, ribs, bumps or bosses, which causethe flow of gas therethrough to be turbulent, imparting a vibratoryresponse in the turbulator plate 230. The vibration in turn prevents thepowdered agent from settling on the lid 222. Thus, the flow of gasthrough the turbulator plate 230 and into the interior space 204 causesboth the vibration of the turbulator plate 230 and the fluidization ofthe powered agent within the canister 202. A magnitude of the vibrationmay be controlled via control of the rate at which gas is passed throughthe turbulator plate 230 as would be understood by those skilled in theart. In this embodiment, the magnitude of vibration of the turbulatorplate 230 is held constant over time, for as long as the user isdepressing a trigger to feed gas to the canister 202. The fluidizedpowder agent exits the canister 202 via the outlet 208, which is not incommunication with the interior 236 of the turbulator plate 230. Theoutlet 208 in this embodiment is coupled to a delivery catheter 226 fordelivering the fluidized powder mixture to the target site.

In an alternate embodiment, as shown in FIG. 18 , a device 200′ issubstantially similar to the device 200 described above, unlessotherwise indicated. In this embodiment, a turbulator plate 230′ extendsalong a portion of a lid 222′, which encloses an interior space 204′defined via a canister 202′, and includes a first opening 232′ and asecond opening 240′ extending through a wall 234′ thereof. Neither thefirst opening 232′ nor the second opening 240′ are in communication withan inlet 206′ and an outlet 208′ of the device 200′. Each of the inlet206′ and the first opening 232′ are configured to be connected to a gassource for supplying gas to the interior space 204′ and the turbulatorplate 230′, respectively. Each of the inlet 206′ and the first opening232′ is connected to the same or different gas sources.

Gas supplied to the turbulator plate 230′ via the first opening 232′passes through the turbulator plate 230′ and exits the turbulator plate230′ via the second opening 240′. Gas may, for example, be supplied tothe turbulator plate 230′ at a constant rate while the powdered agent isbeing fluidized and delivered to the target site to maintain a constantmagnitude of vibration. Alternatively, the flow of gas supplied to theturbulator plate 230′ may be changed over time, or intermittently, tochange a magnitude of vibration, as desired, to optimize the rate ofdelivery of the fluidized powder mixture. It will be understood by thoseof skill in the art, however, that the function of the turbulator plate230′ remains otherwise the same as the device 200, keeping the powderedagent from settling on the lid 222′.

As shown in FIGS. 19 and 20 , a device 300 according to anotherembodiment of the present disclosure is substantially similar to thedevices 100′, 200, unless otherwise indicated. The device 300 comprisesa canister 302 defining an interior space 304 within which a powderedagent (e.g., hemostatic agent) is received and fluidized via a high flowgas for delivery to a target site (e.g., bleeding site) for treatment.The interior space 304 is enclosed via a lid 322 attached to an open endof the canister 302 and gas is supplied to the interior space 304 via aninlet 306 extending through the lid 322. The resulting fluidized powdermixture exits the interior space 304 via an outlet 308 extending throughthe lid 322 to be delivered to the target site. The device 300 alsoincludes a tube 310 extending from a first end 328 connected to theoutlet 308 to a second end 314 extending into the interior space 304.Rather than a single slot extending through a wall of the tube 310,however, the tube 310 includes a plurality of slots 312 distributedabout the tube 310 to prevent uneven distribution of powder within thecanister 302 and prevent powder build up on any side of the tube 310,which may decrease fluidized powder mixture delivery rates.

In one embodiment, as shown in FIG. 20 , the tube 310 includes fourslots 312, distributed about the tube 310 and spaced equidistantly fromone another. The slots 312 in this embodiment are positioned proximatethe first end 328. It will be understood by those of skill in the art,however, that the number, position and configuration of the slots 312may be varied.

As shown in FIG. 21 , a device 400 according to another embodiment ofthe present disclosure is substantially similar to the devices 100′,200, and 300 described above, unless otherwise indicated. The device 400comprises a canister 402 defining an interior space 404 within which apowdered agent 405 is received and fluidized to form a fluidized powdermixture for delivery to a target site of within a living body.Similarly, the device 400 may include a lid 422 enclosing the interiorspace 404 along with an inlet 406 via which gas is supplied to theinterior space 404 to fluidize the powdered agent 405 and an outlet 408via which the fluidized powder agent exits the canister 402 to bedelivered to the target site. The device 400 may also include a tube 410extending into the interior space 404 in communication with the outlet408. The device 400 further comprises a filler chamber 450 coupled tothe canister 402, in communication with the interior space 404 of thecanister 402. The filler chamber 450 houses filler material 452 such as,for example, mock particles, beads, tiny “bounce balls” or a foammaterial, which is injected into the canister 402 as fluidized powdermixture exits the canister 402 to make up for a loss in volume of thepowdered agent as the fluidized powder mixture is delivered to thetarget site. The filler material 452 is injected into the canister 402to maintain a constant ratio of volume of material (e.g., powdered agentand filler) to volume of gas within the canister 402 to maintain adesired rate of delivery of the fluidized powder mixture to the targetsite.

The filler chamber 450 may be connected to the canister 402 so that thefiller material 452 passes from the filler chamber 450 to the canister402 via a filler inlet 454. In one embodiment, the filler chamber 450may also include a gas inlet 456 so that, when a user actuates thedelivery of the fluidized powder mixture to the target site via, forexample, pressing a trigger, gas is supplied to both the canister 402and the filler chamber 450. The gas supplied to the filler chamber 450drives the filler material 452 out of the filler chamber 450 into thecanister 402. The filler chamber 450 may include a pressure regulator toregulate the gas inlet pressure, as necessary, to regulate the volume offiller material 452 being supplied to the canister 402 to correspond tothe volume of powdered agent 405 exiting the canister 402. In oneembodiment, the filler inlet 454 may be sized, shaped and/or otherwiseconfigured to facilitate passage of a single stream of filler material452 (e.g., beads) therethrough into the canister 402.

Filler material 452 is configured to be able to enter the interior space404 of the canister 402, but is prevented from exiting the canister 402during delivery of the fluidized powder mixture. In one embodiment, thisis achieved via a sizing of the individual particles of the fillermaterial 452. For example, the filler material 452 may be sized and/orshaped to prevent it from entering the tube 410 and/or the outlet 408.In other words, each bead or particle of the filler material 452 isselected to be larger than an opening of the tube 410 and/or an openingof the outlet 408. The filler material 452 is sized and shaped to belarge enough to prevent the filler material from exiting the canister402, while also being configured to bounce off walls 403 of the canister402 as the powdered agent is moved within the interior space 404 and isfluidized to prevent clogging of the device 400.

Thus, in use, the canister 402 of the device 400 loses powder duringdelivery of the fluidized powder agent, but will compensate for the lossby simultaneously supplying the canister 402 with a corresponding volumeof filler material 452. The rate of delivery of filler material 452 intothe canister 402 may be determined by calculating a powder volume thathas been lost given a fluidized powder mixture delivery rate, andadjusting it based on volume and flow rate differences of the fillermaterial 452 versus the powdered agent 405. The rate of delivery offiller material 452 into the canister 402 is selected to compensate forthe loss in volume of the powder 405 to maintain a substantiallyconstant fluidized powder mixture delivery rate. Although the inlet 406of the canister 402 and the gas inlet 456 of the filler chamber 450 areshown and described as coupled to a single gas source, it will beunderstood by those of skill in the art that each of the inlet 406 andthe gas inlet 456 may be coupled to separate gas sources, each of whichsupply gas to the inlet 406 and the gas inlet 456 when delivery offluidized powder mixture to the target site is actuated and/ortriggered.

As shown in FIGS. 22 and 23 , a device 500 may be substantially similarto the device 400, unless otherwise indicated. The device 500 comprisesa canister 502 defining a first interior space 504 within which powderedagent is received and fluidized to deliver a fluidized powder mixture toa target site of a patient for treatment. Rather than a separate fillerchamber, however, the canister 502 defines both the first interior space504 and a second interior space 550 which, when the device 500 is in anoperative position, extends above the first interior space 504. Inaddition, rather than filling the first interior space 504 with a fillermaterial to maintain a constant volume of material (powder and/orfiller) therein, the second interior space 550 houses additionalpowdered agent, which may be supplied to the first interior space 504via gravity as the fluidized powder mixture exits the first interiorspace 504 to be delivered to the target site. An inlet and outlet (notshown) are in communication with the first interior space 504 so thatonly the powdered agent contained within the first interior space 504 isfluidized to form the fluidized powder mixture and only the powderedagent within the first interior space 504 is permitted to exit thedevice 500 to the target site.

The second interior space 550 may be in communication with the firstinterior space 504 via an opening 554 extending therebetween. The device500 further comprises a door 558 movable between a first configurationprior to commencement of a treatment procedure, as shown in FIG. 22 ,and a second configuration during a course of treatment, as shown inFIG. 23 . In the first configuration, the door 558 may extend over theentire opening 554 when fluidized powder mixture is not being delivered,to prevent the passage of any powdered agent from the second interiorspace 550 to the first interior space 504. As shown via the dotted linein FIG. 22 , the first interior space 504 contains a given volume ofpowdered agent therein.

When the user actuates and/or triggers delivery of the fluidized powdermixture, as shown in FIG. 23 , movement of the door 558 may also betriggered so that the door 558 opens to expose the opening 554,permitting the passage of powdered agent from the second interior space550 to the first interior space 504. Actuation of the door 558 may betriggered in any of a number of different ways. For example, the door558 may include a motor that is activation, upon actuation of the device500, a magnetic mechanism that uses magnetism to open the door 558 uponactivation and/or pressure differentials created by the pressureincrease upon device actuation. The second interior space 550 mayinclude an angled surface 560 which directs the powdered agent towardthe opening 554 so that, when the door 558 is open, the powdered agentwithin the second interior space 550 is permitted to fall into the firstinterior space 504. Thus, the first interior space 504 is passively fedwith the additional powdered agent via gravity. As shown via the dottedline in FIG. 23 , the volume of powder within the first interior space504 should remain constant during the course of treatment since thefirst interior space 504 is being fed via the second interior space 550as the fluidized powder mixture is being delivered. The opening 554 maybe sized and/or otherwise configured to allow powdered agent to falltherethrough at a controlled rate selected to keep the volume ofpowdered agent within the first interior space 504 substantiallyconstant.

Although the additional powdered agent within the second interior space550 is described as being passively fed into the first interior space504 via gravity, in an alternate embodiment, as shown in FIGS. 24 and 25, powdered agent within a second interior space 550′ of a canister 502′of a device 500′ may be actively fed into a first interior space 504′ ofthe canister 502′ via, for example, a turbine 562′ which may be poweredvia a gas flow. In this embodiment, a rotatable paddle 564′ is mountedwithin an opening 554′ extending between the first and second interiorspaces 504′, 550′. The rotatable paddle 564′ is connected to the turbine562′, which is positioned along an exterior of the canister 502′ andhoused within a gas flow path 566′. The gas flow path 566′ may beconfigured as a connecting element 524′ connecting a gas source to aninlet (not shown), which permits passage of gas therethrough into thefirst interior space 504. Thus, the connecting element 524′, in thisembodiment, extends along an exterior side of the canister 502′ toaccommodate the turbine 562′.

In a first configuration of device 500′, as shown in FIG. 24 , in whichdelivery of fluidized powder mixture is not actuated and thus no gasflows through the flow path 566′, the turbine 562′ does not rotate andthus no powdered agent is permitted to pass from the second interiorspace 550′ to the first interior space 504′. As shown in FIG. 25 , whendelivery of the fluidized powder mixture is actuated, in a secondconfiguration, the turbine 562′ is rotated via a flow of gas passingthrough the gas flow path 566′. Rotation of the turbine 562′correspondingly rotates the paddle 564′ to actively drive the powderedagent within the second interior space 550′ through the opening 554′ andinto the first interior space 504′. Since the flow of gas is initiatedwhen a user actuates and/or otherwise triggers delivery of a fluidizedpowder mixture to a target site, a supply of powdered agent from thesecond interior space 550′ to the first interior space 504′ will occursimultaneously with the exiting of powdered agent (e.g., the fluidizedpowder mixture) from the first interior space 504′ to maintain asubstantially constant volume of powdered agent within the firstinterior space 504′. Maintaining the volume of powdered agent within thefirst interior space 504′ will correspondingly maintain a substantiallyconstant delivery rate of the fluidized powder mixture.

Although the above embodiment describes a single gas source/supply, itwill be understood by those of skill in the art that the turbine 562′may be driven via a gas source separate from a gas source connected toan inlet of the device 500′ so long as a volume of powdered agentsupplied from the second interior space 550′ to the first interior space504′ corresponds to a volume of powdered agent exiting the firstinterior space 504′. In addition, although the embodiment describesactive transfer of the powdered agent via a gas powered turbine, activetransfer from the second interior space 550′ to the first interior space504′ may also occur via other mechanisms.

As shown in FIG. 26 , a device 1200 for fluidizing and delivering apowdered agent (e.g., hemostatic agent) according to an embodiment ofthe present disclosure comprises a canister 1202 and a piston 1204movably coupled to the canister 1202. The canister 1202 is configured toreceive the powdered agent within an interior space 106 thereof. Thecanister 1202 is subsequently filled with a gas via an inlet 1208 thatmay be connected to a gas source via, for example, a tubular member1212. The powder is fluidized via the gas to form a two-phase mixturethat may be sprayed onto the target site (e.g., bleeding site) via acatheter 1214 connected to an outlet 1210. The catheter 1214 is sizedand shaped and sufficiently flexible to be endoscopically inserted intoa patient body to the target site (e.g., along a tortuous path traversedby a flexible endoscope through a body lumen accessed via a natural bodyorifice). In order to maintain a substantially constant delivery rate ofthe mixture to the target site, the piston 1204 is movable relative tothe canister 1202 to decrease a volume of the interior space 1206,during the course of treatment of the target site. Thus, as a volume ofpowder within the canister 1202 is decreased, the volume of the interiorspace 1206 is also decreased to maintain a substantially constant powdervolume to canister volume ratio. The piston 1204 may be moved relativeto the canister 1202 in any of a number of different ways. In thisembodiment, the piston 1204 is moved via a pneumatic cylinder or motor1216.

The canister 1202 of this embodiment is formed of a rigid material todefine the interior space 1206, which is configured to receive thepowdered agent along with the gas to form the gaseous fluid mixture thatis sprayed on the target site to provide treatment thereto. The canister1202 extends longitudinally from an open first end 1216 to a closedsecond end 1218. The piston 1204 is movably coupled to the canister 1202at the first end 1216 and is movable toward the second end 1218 toreduce the volume of the interior space 1206. The piston 1204 enclosesthe interior space 1206 so that the powder, gas and/or the gas mixturedo not leak from the canister 1202, and exit the canister 1202 via theoutlet 1210 and from there into the catheter 1214 to exit toward thetarget site. Thus, the piston 1204 of this embodiment is received withinthe open first end 1216 and is substantially sized and shaped tocorrespond to a size and shape of an opening at the first end 1216. Inone example, the canister 1202 is substantially cylindrical while thepiston 1204 is substantially disc-shaped to be received within the openfirst end 1216 of the canister 1202. The canister 1202 is sized andshaped so that the piston 1204 is movable along at least a portion of alength thereof toward the second end 1218 to reduce a volume of theinterior space 1206 while also preventing leakage of anyfluids/substances received within the interior space 1206. In oneexample, the piston 1204 includes a sealing ring extending about acircumference thereof to prevent leakage of any powder, gas and/or fluidtherepast.

As described above, the device 1200 also includes the inlet 1208 viawhich gas is introduced into the interior space 1206 and the outlet 1210via which the fluidized powder is delivered to the catheter 1214 toreach the target site. In one embodiment, each of the inlet 1208 and theoutlet 1210 are configured as an opening extending through a portion ofthe piston 1204 to be connected to the tubular member 1212 and thecatheter 1214, respectively. It will be understood by those of skill inthe art, however, that the inlet 1208 and the outlet 1210 may bepositioned on or along any portion of the canister 1202 and/or thepiston 1204 so long as the inlet 1208 is configured to receive a highpressure gas therethrough and into the interior space 1206, and theoutlet 1210 is connectable to a delivery element such as, for example,the catheter 1214, which delivers the fluidized mixture from theinterior space 1206 to the target site. It will also be understood bythose of skill in the art, that although the inlet 1208 is described asconnected to the gas source via the tubular member 1212, the inlet 1208may be connected to the gas source via any of a number of couplings solong as sufficient gas flow is deliverable therethrough. In addition,although the outlet 1210 is shown and described as an opening extendingthrough the piston 1204, it will be understood by those of skill in theart that the outlet 1210 may also be configured to include a hypotubeextending into the interior space 1206 so that fluidized mixture formedwithin the interior space 1206 may be received within the hypotube to bedelivered to the target site via the catheter 1214.

In this embodiment, the piston 1204 is movable relative to the canister1202 via a pneumatic cylinder or motor 1220. The device 1200 may beprogrammed to include one or more inputs such as, for example, time.When it is desired to deliver the fluidized mixture to the target site,the user may initiate delivery using a controller such as a trigger. Forexample, when the user depresses the trigger to deliver the fluidizedmixture, the piston 1204 moves toward the second end 1218 at a presetrate. When the user releases the trigger, the piston 1204 may stop,maintaining its position relative to the canister 1202 until the userdepresses the trigger again. Alternatively or in addition, the device1200 may use other inputs such as, for example, inputs based on flowand/or pressure sensors within the interior space 1206 of the canister1202, the inlet 1208 and/or the outlet 1210.

Although the piston 1204 of the device 1200 is described and shown asdriven via the pneumatic cylinder or motor 1220, it will be understoodby those of skill in the art that the piston 1204 may be moved from itsinitial position proximate the first end 1216 toward the second end 1218via any of a variety of different drive mechanisms, examples of whichwill be described in further detail below. In addition, although thepiston 1204 is shown as forming a base (e.g., bottom portion) of thecanister 1202, it will be understood by those of skill in the art thatthe piston 1204 may be coupled to the canister 1202 in any of a numberof configurations. In particular, the piston 1204 may also be configuredas a lid (e.g., top portion) of the canister 1202. In a furtherembodiment, the device 1200 may include more than one piston 1204, eachof which are movable relative to the canister 1202 to reduce the volumeof the interior space 1206 thereof.

According to example method using the device 1200, the canister 1202 maybe filled with the powdered agent such as, for example, a hemostaticagent, prior to assembly of the device 1200. Upon filling the canister1202 with a desired amount of powder, the canister 1202 and the piston1204 are assembled, the inlet 1208 is coupled to the gas source via, forexample, the tubular member 1212, and the outlet 1210 is coupled to thecatheter 1214. The catheter 1214 may then be inserted to the target sitewithin the body through a working channel of a delivery device such asan endoscope. The user may depress a trigger or other controller tointroduce a high flow gas into the interior space 1206 of the canister1202 to form the fluidized mixture and deliver the fluidized mixture tothe target site (e.g., a bleeding site) to provide treatment thereto.When the trigger is depressed, the pneumatic cylinder or motor 1220 isoperated to move the piston 1204 toward the second end 1218 reducing thevolume of the interior space 1206 by an amount corresponding to thereduction in the volume of powder remaining within the interior space1206 as reduced the powder exits the canister 1202 via the outlet 1210.When the user releases the trigger, both the delivery of the fluidizedmixture and the movement of the piston 1204 are halted. Thus, the piston1204 moves only while the fluidized mixture is being delivered so thereduction in the volume of the interior space 1206 corresponds to thereduction in the volume of powder remaining housed within the interiorspace 1206. As described above, a rate of movement of the piston 1204may be based on inputs such as, for example, time, flow and/or pressurewithin the canister 1202, inlet 1208 and outlet 1210. In one embodiment,the piston 1204 is configured to move at a rate which maintains asubstantially constant ratio of the volume of the interior space 1206available in the canister 1202 to the volume of remaining powder tomaintain a substantially constant fluidized mixture delivery rate.

As shown in FIG. 27 , a device 1300 according to another embodiment issubstantially similar to the device 1200, comprising a canister 1302 anda piston 1304 movably coupled thereto to move from an initial positionproximate a first end 1316 of the canister 1302 toward a second end 1318to reduce a volume of an interior space 1306 of the canister 1302 as afluidized powder mixture is delivered to a target site. Similarly to thedevice 1200, high flow gas is delivered to the interior space 1306 tofluidize a powdered agent received within the canister 1302 to form afluidized mixture for delivery to a target site in the body. Gas isreceived within the canister 1302 via an inlet 1308 connected to a gassource via, for example, a tubular member 1312. The fluidized mixture isdelivered to the target site via a delivery catheter 1314 connected toan outlet 1310 of the device 1300. In this embodiment, however, thepiston 1304 is moved via a chamber 1320 including an expandable member1322, which expands as gas is received therein. In particular, when auser triggers a controller (e.g., depresses a trigger) to deliver thefluidized mixture to the target site, a portion of the gas is divertedinto the expandable member 1322 so that the gas expands the expandablemember 1322, as shown in broken lines in FIG. 27 , thereby moving thepiston 1304 toward the second end 1318.

The chamber 1320, which houses the expandable member 1322, in thisembodiment is connected to the first end 1316 of the canister 1302 on aside of the piston 1304 opposite the interior space 1306 so that, as theexpandable member 1322 expands, the piston 1304 is moved toward thesecond end 1318 of the canister 1302. The expandable member 1322 is alsoconnected to the gas source via a connecting member 1324, which includesa one way valve so that gas may pass therethrough in a first directioninto the expandable chamber 1322, but is prevented from flowing in asecond direction out of the expandable chamber 1322. As described above,gas is directed into the chamber 1320 only while the fluidized mixtureis being delivered to the target site so that a reduction of the volumeof the interior space 1306 corresponds to a reduction in volume of thepowdered agent within the canister 1302. Similarly to the device 1200,the device 1300 may receive inputs corresponding to flow, pressureand/or time, that may control a rate at which the piston 1304 is movedtoward the second end 1318. It will be understood by those of skill inthe art that the device 1300 may be used in a manner substantiallysimilar to the device 1200.

As shown in FIGS. 28 and 29 , a device 1400 according to anotherembodiment may be substantially similar to the devices 1200, 1300described above, comprising a canister 1402 for receiving a powderedagent within an interior space 1406 thereof and a piston 1404 movablycoupled to the canister 1402. High flow gas is delivered to the interiorspace 1406 via an inlet 1408 that is connected to a gas source to form afluidized powder mixture for delivery to a target treatment area via adelivery catheter 1414 connected to an outlet 1410 of the device 1400.The piston 1404 is movable from an initial position proximate a firstend 1416 of the canister 1402 toward a second end 1418 to reduce avolume of the interior space 1406 as a volume of the powdered agentwithin the interior space 1406 is reduced. The device 1400, however,further includes a turbine 1426 connected to a threaded rod 1428 towhich the piston 1404 is threadedly coupled. The turbine 1426 is housedwithin a bypass 1424 connected to the first end 1416 if the canister1402. A portion of the gas is diverted through the bypass 1424 when theuser triggers a controller to deliver the fluidized mixture. The flow ofgas through the bypass 1424 spins the turbine 1426, thereby causing thethreaded rod 1428 to rotate about a longitudinal axis thereof. As thethreaded rod 1428 is rotated, the piston 1424 is moved longitudinallytherealong toward the second end 1418.

As shown in FIG. 29 , the bypass 1424 including a first opening 1430through which gas is received and second opening 1432 through which gasexits so that gas flows through the bypass 1424 from the first opening1430 to the second opening 1432 to rotate the turbine 1426 housedtherein. The threaded rod 1428 is connected to the turbine 1426 so thatrotation of the turbine 1426 results in rotation of the threaded rod1428. Since the piston 1404 is threaded over the rod 1428, rotation ofthe threaded rod 1428 causes the piston 1404 to be moved longitudinallytherealong. The piston 1404 is threaded over rod 1428 so that rotationof the threaded rod 1428 via the flow of gas through the bypass 1424results in the longitudinal movement of the piston 1404 toward thesecond end 1418. Similarly to the device 1300, a portion of the gas isonly diverted through the bypass 1424 during delivery of the fluidizedmixture so that a reduction in volume of the interior space correspondsto a volume of powder remaining in the interior space 1406. It will beunderstood by those of skill in the art that the device 1400 may be usedin a manner substantially similar to the devices 1200, 1300, asdescribed above.

As shown in FIG. 30 , a device 1600 according to another embodiment ofthe present disclosure may be substantially similar to the devices 1200,1300, and 1400, described above, comprising a canister 1602 configuredto receive a powdered agent therein for fluidization via a gas. Similarto the devices 1200, 1300, and 1400, a volume of an interior space 1606of the canister 1602 is reduced as a fluidized mixture is delivered to atarget site for treatment. Rather than reducing the volume of theinterior space 1606 via a movable piston, however, the device 1600includes an expandable member 1604 which expands into the interior space1606, as shown in broken lines in FIG. 30 , of the canister 1602 toreduce the volume thereof.

Similarly to the devices 1200, 1300, and 1400, gas is supplied into thecanister 1602 via an inlet 1608, which may be connected to a gas sourcevia a connecting member 1612. The fluidized mixture is delivered to thetarget site via a delivery catheter 1614 connected to an outlet 1610.The device 1600 further comprises a secondary chamber 1620 connected tothe canister 1602. Similarly to the device 1300 described above, aportion of the gas from the gas source may be diverted into thesecondary chamber during delivery of the fluidized mixture. An interiorspace 1634 of the secondary chamber 1620 is separated from the interiorspace 1606 of the canister 1602 via the expandable member 1604. In thisembodiment, the expandable member 1604 is configured as an expandablediaphragm extending between the canister 1602 and the secondary chamber1620 so that, when gas is received within the interior space 1634 of thesecondary chamber 1620, a pressure differential between the interiorspace 1634 of the secondary chamber 1620 and the interior space 1606 ofthe canister 1602 causes the expandable member to deflect into thecanister 1602, as shown in broken lines in FIG. 30 reducing the volumeof the interior space 1606.

As described above with respect to the devices 1300, 1400, gas is onlydiverted into the secondary chamber 1620 during the delivery of thefluidized mixture. When delivery is triggered gas is diverted to thesecondary chamber 1620. When the user releases the trigger for delivery,delivery of gas to the secondary chamber 1620 is halted. As alsodiscussed above, the amount of flow diverted to the secondary chamber1620 may be dictated by time, pressure and/or flow detected within thedevice 1600. As more gas flows into the secondary chamber 1620, itspressure increases to force the diaphragm to deflect further into theinterior space 1606 of the canister 1602. Thus, the device 1600 may beutilized in a manner substantially similar to the devices describedabove.

Although the device 1600 shows and is described with respect to a singleexpandable diaphragm, it will be understood by those of skill in the artthat the device 1600 may include more than one expandable diaphragm andthe expandable member may have any of a variety of shapes andconfigurations.

As shown in FIG. 31 , a device 1700 according to another embodiment maybe substantially similar to the device 1600, described above, comprisinga canister 1702 including an expandable member 1704 which expands toreduce a volume of a first interior space 1706 of the canister 1702 as apowdered agent received therewithin is fluidized and delivered to atarget site for treatment. In this embodiment, however, the expandablemember 1704 may be housed within the canister 1702 to define both thefirst interior space 1706 in which the powdered agent is fluidized and asecond interior space 1708 into which a portion of a gas may be divertedto cause the expandable member 1704 to deflect into the first interiorspace 1706 to reduce a volume thereof. A first end 1716 of the canister1702 may be substantially closed via a base portion 1740. An inlet 1708for supplying gas into the first interior space 1706 and an outlet 1710via which the fluidized mixture is delivered to the target site mayextend through the base portion 1740 in communication with the firstinterior space 1706.

The expandable member 1704 may, in one example, have a substantiallycylindrical configuration. The cylindrically shaped expandable member1704 is housed within the canister 1702 so that an interior of theexpandable member 1704 defines the first interior space 1706 withinwhich the powdered agent is housed and subsequently fluidized via a highflow gas supplied from a gas source thereto via the inlet 1708. Thesecond interior space 1720 is defined via an exterior surface 1736 ofthe expandable member 1704 and an interior surface 1738 of the canister1702 so as the fluidized mixture is delivered to the target site fromthe first interior space 1706 via a delivery catheter 1714 connected tothe outlet 1710, a portion of gas from the gas source gas is divertedinto the second interior space 1738 via a connecting element 1724. Apressure differential between the first and second interior spaces 1706,1720 causes the expandable member 1704 to deflect into the firstinterior space 1706, as shown in broken lines in FIG. 31 , toward anexpanded configuration, as shown via the broken lines in FIG. 31 ,reducing the volume of the first interior space 1706 as a volume of thepowder in the first interior space 1706 is reduced. In one embodiment,in the expanded configuration, the expandable member 1704 may form asubstantially hourglass shape. It will be understood by those of skillin the art, however, that the expandable member 1704 may have any of avariety of shapes and configurations so long as the expandable member1704, when expanded, reduces a volume of the first interior space 1706.Similarly to the devices described above, gas is only diverted into thesecond interior space 1720 during delivery of the fluidized mixture andmay be controlled via inputs including time, and/or flow and/or pressurewithin the device 1700.

Although the device 1700 is shown and described as including asubstantially cylindrically shaped expandable member 1704, it will beunderstood by those of skill in the art that the expandable member 1704may have any of a variety of shapes so long as the expandable memberdefines first and second interior spaces 1706, 1720, as described above.

As shown in FIG. 32 , a device 1800 according to another embodiment maybe substantially similar to the device 1700 described above, comprisinga canister 1802 and an expandable member 1804 defining a first interiorspace 1806, in which a powdered agent is fluidized via gas from a gassource to form a fluidized mixture, and a second interior space 1820,which receives a portion of gas diverted from the gas source duringdelivery of the fluidized mixture to a target treatment area. The firstinterior space 606 is defined via an interior wall 1805 of theexpandable member 1804. The second exterior space 1820 is defined via anexterior wall 1836 of the expandable member 1806 and the interiorsurface 1838 of the canister 1802. In this embodiment, however, theexpandable member 1804 extends from a first end 1816 of the canister1802 to a second end 1818 of the canister 1802 so that, in an initialbiased configuration, the expandable member 1804 may substantiallycorrespond in shape to the canister 1802. As the second interior space1820 is filled with diverted gas, however, the expandable member 1804deflects into the first interior space 1806, as shown in broken lines inFIG. 32 , increasing a volume of the second interior space 1820 andthereby reducing a volume of the second interior space 1820.

Similarly to the device 1700, the device 1800 also includes a baseportion 1840 at a first end 1816 of the canister 1802 for enclosing thefirst and second interior spaces 1806, 1820. An inlet 1808 and an outlet1810 extend through the base portion 1840 in communication with thefirst interior space 1806 so that gas may be supplied thereto via theinlet 1808 to fluidize the powdered agent therein and so that thefluidized mixture may be delivered to the target site via the outlet1810. A portion of the gas from the gas source may be diverted into thesecond interior space 1820 via a connecting element 1824, which may bepositioned along the base portion 1840 in communication with the secondinterior space 1820.

As described above, during delivery of the fluidized mixture to thetarget site, a portion of the gas is diverted into the second interiorspace 1820 so that a pressure differential between the first and secondinterior spaces 1806, 1820 causes the expandable member to be divertedradially inward, as shown in broken-lines in FIG. 32 , to reduce thevolume of the first interior space 1806. Thus, as the volume of thepowdered agent within the first interior space 1806 is reduced, thevolume of the first interior space 1806 is correspondingly reduced tomaintain a substantially constant delivery rate of the fluidizedmixture. In a diverted configuration, the expandable member 1804 maytake on a substantially conical shape. It will be understood by those ofskill in the art, however, that the expandable member 1804 may have anyof a configurations, shapes and sizes so long as the expandable member1804 is formed of a flexible, deflectable material which defines both afirst interior space 1806 within walls thereof, and a second interiorspace 1820 between the expandable member 1804 and walls of the canister1802.

As shown in FIG. 33 , a device 1900 according to another embodiment maybe substantially similar to the devices 1600, 1700, and 1800 describedabove, comprising a canister 1902 and an expandable member 1904, whichexpands to reduce a volume of an interior space 1906 of the canister1902 as a powdered agent is fluidized and delivered to a target site oftreatment. The volume of the interior space 1906 is reduced tocorrespond to a reduction in a volume of the powdered agent within theinterior space 1906. The expandable member 1904 in this embodiment,however, is configured as an expandable balloon housed within theinterior space 1906. Thus, as a volume of the balloon 1904 is increasedas it is inflated, the volume of the interior space 1906 is decreased.

Similarly to the devices 1600, 1700, and 1800, the device 1900 includesan inlet 1908 for supplying a gas to the interior space 1906 to fluidizethe powdered agent and an outlet 1910 via the fluidized mixture isdelivered to the target site. The inlet and outlet 1908, 1910 may beextend through a base portion 1940 of the device 1900 which is coupledto an end of the canister 1902 to define the interior space 1906. Aportion of the gas supplied to the device 1900 may be diverted to theexpandable member 1904 via a connecting element 1924 to cause theballoon to become inflated, filling the interior space 1906. Asdescribed above, the inlet 1908 may have any of a variety ofconfigurations and, in one embodiment, may include a hypotube 1911extending into the interior space 1906. The hypotube 1911 may include aslot 1944 extending through a wall thereof along a portion thereof. Theinflated expandable member 1904 may fill the space, surrounding thehypotube 1911 without restricting gas and powder flow through the slot1944. Although the hypotube 1911 is described as including the slot1944, it will be understood by those of skill in the art that the term“slot” may refer to any opening or hole extending through a wallthereof.

The connecting element 1924 may be coupled to the base portion 1940, asshown, to deliver gas to the expandable member 1904. It will beunderstood by those of skill in the embodiment, that the connectingelement 1920 may extend through the interior space 1906 to connect tothe expandable member 1904. Alternatively, as shown in FIG. 34 , adevice 1900′ may have a separate feed line 1924′ which extends through aportion of a canister 1902′ to supply gas to an expandable member 1904′housed therein. It will be understood by those of skill in the art thatan expandable member 1904, 1904′ having a balloon configuration may besupplied with gas for inflating the expandable member via any of avariety of mechanisms.

Catheter 190 is shown in FIG. 35 in a coiled, rolled-up configuration.Catheter 190 includes a proximal end 191, a distal end 193, and anintermediate portion 192 connecting proximal end 191 and distal end 193.Proximal end 191 may be connected to outlet 34 by any mechanism, such asa screw or snap fit mechanism. Alternatively, proximal end 191 may be acomplementary luer, e.g. a male or a female luer, to a luer provided atoutlet 34. As shown in FIG. 35 , proximal end 191 may include abutterfly-shaped device to assist in screwing or otherwise attachingcatheter 190 to application device 30. When a propellant fluid andmaterial mixture is dispensed from application device 30, the mixturemay travel through catheter 190 (preferably in an unrolledconfiguration) and may be dispensed from distal end 193 at the targetsite. Catheter 190 may be any size appropriate for introducing thedevice into a patient while maintaining column strength such thatcatheter 190 does not buckle when passed though an endoscope. Forexample, catheter 190 may be approximately 200-275 cm, and preferablyapproximately 210-250 cm. Further, a diameter of catheter 190 may beapproximately seven (7) to eight (8) French, and a wall thickness ofcatheter 190 may be approximately 0.05-0.15 inches, or preferablyapproximately 0.1 inches. In addition, catheter 190 may be nylon or anyother suitable material. However, the size and the material of thecatheter is not limited thereto.

Although many features are described as cylindrical, the shape of theelements are not limited thereto. Rather, the features may be any shapesuitable for regulator 40 to properly regulate a fluid dispersion fromcontainment device 20, 20′. Moreover, unless described otherwise, thestructural elements of application device 30 and/or regulator 40, 40′may be any material known in the art, including but not limited to ametal alloy, a ceramic, and/or a resin. Further, although the aboveembodiments are described as diverting a portion of gas from a gassource/supply to drive movement of a piston or expansion of anexpandable member, it will be understood by those of skill in the artthat the devices described above may include one or more gas source(s)for providing gas to both the interior space and for driving the pistonand/or causing expansion of the expandable member.

It will be apparent to those skilled in the art that variousmodifications and variations can be made to the disclosed device withoutdeparting from the scope of the disclosure. For example, any material orfluid may be contained in the chamber and may mix with the propellantfluid to be expelled from the application device to a target location.Additionally, or alternatively, unless otherwise specified, the medicaldevice described herein may be formed of any metal, plastic, or ceramic,or any combination thereof, suitable for use in medical applications.Other embodiments of the disclosure will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

What is claimed is:
 1. A medical device, comprising: an applicationdevice having a first fluid path therethrough; and a first containermovably attached to the application device, wherein the first containerand the application device have a second fluid path therethrough,wherein the first container includes an inner chamber that isintermediate proximal and distal portions of the second fluid path, andwherein the tube extends through the inner chamber, and the tubeincludes a port for receiving an agent stored in the inner chamber;wherein the inner chamber is fluidly isolated from the distal portion ofthe second fluid path at a first position of the tube relative to thefirst container such that the distal portion of the second fluid path isnot in communication with the agent from the inner chamber through theport, and wherein the inner chamber is fluidly coupled to the proximaland distal portions of the second fluid path at a second position of thetube relative to the first container such that the distal portion of thesecond fluid path is in communication with the agent from the innerchamber through the port, wherein the first container is attached to theapplication device when in the first position and the second position;wherein; the first fluid path bypasses the first container, and thepassage of fluid of fluid through the first fluid path is separatelycontrollable from the passage of fluid through the second fluid path. 2.The medical device according to claim 1, further comprising: a secondcontainer including a propellant fluid and configured to be attached toan inlet of the application device.
 3. The medical device according toclaim 2, wherein the application device further includes a lockingmechanism for securing the second container to the application device.4. The medical device according to claim 3, wherein the lockingmechanism includes: a lever pivotally connected to the applicationdevice; a piston connected to the lever and contacting the secondcontainer, wherein in a first position of the lever, the secondcontainer is fluidly decoupled from the application device, and in asecond position of the lever, the second container is fluidly coupled tothe application device.
 5. The medical device according to claim 4,wherein a protrusion extends from a surface of the piston toward theinlet, wherein a void extends into the first container from a surfacefacing the piston, and wherein the protrusion extends into the void andmaintains a fixed position of the first container with respect to thepiston.
 6. The medical device according to claim 2, wherein the innerchamber includes one or more protrusions extending from a bottom surfaceof the inner chamber into the inner chamber, and wherein the one or moreprotrusions are configured to change a fluid path of the propellantfluid in the inner chamber.
 7. The medical device according to claim 2,wherein the application device further includes first and secondactuation devices, wherein the first actuation device is configured tocontrol the propellant fluid in the first fluid path, and wherein thesecond actuation device is configured to control the propellant fluid inthe second fluid path.
 8. The medical device according to claim 1,wherein the first container includes (a) a chamber inlet between theinner chamber and the proximal portion of the second fluid path, and (b)a chamber filter, wherein the chamber filter is configured to allow afluid to enter the inner chamber from the proximal portion of the secondfluid path, and wherein the chamber filter is configured to prevent amaterial disposed in the first container from entering the proximalportion of the second fluid path.
 9. The medical device according toclaim 1, wherein a sheath is disposed about the tube, wherein the portis covered by the sheath when the tube is positioned relative to thefirst container at the first position, and wherein the port is exposedfrom the sheath when the tube is positioned relative to the firstcontainer at the second position.
 10. The medical device according toclaim 9, wherein the inner chamber further includes an attachment memberfixedly attached to the sheath and an outer surface of the firstcontainer, and wherein rotation of the outer surface causes the sheathto move longitudinally on the tube.
 11. The medical device according toclaim 10, wherein the application device includes a groove having afirst end and a second end, wherein the first container includes a camextending from the outer surface of the first container, wherein the camis within the groove, wherein the cam is disposed at the first end ofthe groove when the tube is positioned relative to the first containerat the first position, and wherein the cam is disposed at the second endof the groove when the tube is positioned relative to the firstcontainer at the second position.
 12. The medical device according toclaim 1, wherein the second fluid path includes a pressure releasemechanism configured to release fluid when a pressure of a fluid in thesecond fluid path is greater than a threshold, and wherein the thresholdis greater than a desired pressure of a fluid at an outlet of the secondfluid path.
 13. The medical device according to claim 12, wherein thepressure release mechanism includes a burst disc and is disposed in theinner chamber of the first container.
 14. The medical device accordingto claim 2, wherein the inlet of the application device includes asecond pressure release mechanism, and wherein actuation of the secondpressure release mechanism releases the propellant fluid from the secondcontainer.
 15. The medical device according to claim 1, furthercomprising: a catheter attached to an outlet of the distal portion ofthe second fluid path, via a luer connection.
 16. A medical device,comprising: an application device having a first fluid paththerethrough; and a container movably attached to the applicationdevice, wherein the container and the application device have a secondfluid path therethrough, wherein the first container has an innerchamber having an inlet configured to be fluidly coupled to a proximalportion of the second fluid path and an outlet configured to be fluidlycoupled to a distal portion of the second fluid path; wherein a tubeextends through the inner chamber of the container, and the tubeincludes a port for receiving an agent stored in the inner chamber, andwherein the inner chamber is fluidly decoupled from the distal portionof the second fluid path when the container is attached to theapplication device with the tube at a first position such that agentfrom the inner chamber is not in fluid communication with the distalportion of the second fluid path via the port, and the inner chamber isfluidly coupled to the proximal and distal portions of the second fluidpath when the container is attached to the application device with thetube at a second position such that the agent from the inner chamber isin fluid communication with the distal portion of the second fluid pathvia the port.
 17. The medical device according to claim 16, wherein asheath is disposed about the tube, wherein the port is covered by thesheath when the tube within the inner chamber of the container is at thefirst position, and wherein the port is exposed from the sheath when thetube within the inner chamber of the container is at the secondposition.
 18. The medical device according to claim 16, wherein theapplication device includes a groove having a first end and a secondend, wherein the container includes a cam extending from an outersurface of the container, wherein the cam is within the groove, whereinthe cam is disposed at the first end of the groove when the tube withinthe inner chamber of the container is at the first position, and whereinthe cam is disposed at the second end of the groove when the tube withinthe inner chamber of the container is at the second position.
 19. Amedical device, comprising: an application device having a first fluidpath, an inlet, and an outlet; and a first container attached to theapplication device, wherein the first container and the applicationdevice have a second fluid path therethrough, wherein the firstcontainer includes an inner chamber between distal and proximal portionsof the second fluid path, wherein the inner chamber includes an inflowconfigured to be fluidly coupled to the proximal portion of the secondfluid path and an outflow configured to be fluidly coupled to the distalportion of the second fluid path, and wherein a tube extends through theinner chamber, and the tube includes at least one port fluidly isolatedfrom the inner chamber when the tube within the inner chamber of thefirst container is in a first position, such that the agent from theinner chamber is not in communication with the distal portion of thesecond fluid path via the at least one port, and fluidly coupled to theinner chamber when the tube within the inner chamber of the firstcontainer is in a second position, such that the agent from the innerchamber is in fluid communication with the distal portion of the secondfluid path via the at least one port; wherein fluid from the first fluidpath travels from the inlet to the outlet, bypassing the firstcontainer, and the first containers attached to the application devicewhen the tube is in the first position and the second position.
 20. Themedical device according to claim 19, further comprising: a secondcontainer including a propellant fluid; and a locking mechanism, whereinthe locking mechanism includes: a lever pivotally connected to theapplication device; a piston connected to the lever and contacting thesecond container, wherein in a first position of the lever, the secondcontainer is fluidly decoupled from the application device, and in asecond position of the lever, the second container is fluidly coupled tothe application device.